Adverse event – EAAAM – case presentation

Introduction: The analysis of this case as a sentinel event is in accordance with the London Protocol. The process of adverse events investigation must be carried out in an open and correct environment with the aim of learning from errors and not punishment.

Diagnosis: right groin post-procedural abscess (ove-rinfected hematoma), PTCA with drug-coated stent on LAD (anterior ascending coronary artery – 85% stenosis), aggravated ICM, HTA 2 high risk group, HF NYHA II, III, insulin-dependent DM, obesity, secondary right femoral thrombophlebitis, massive pulmo-nary embolism, exitus.

Reasons for admission: 80 y.o. female patient, obese, diabetic, hypertensive, presents to the ER with fever, chills, swelling, post-procedural right inguinal edema (overinfected hematoma); released 5 days earlier from Cardiology after PTCA with stent implantation. Is ad-mitted to the ER for emergency surgery for the groin abscess evacuation, performed on the same day.

Analysis of the causes of the adverse event

Direct causes: Lack of measures for reducing the probability of unwanted consequences` occurrence. Re-puncturing the femoral artery in the same spot within 5 days and repeating the AngioSeal-hemostasis represent a error of commission, with haemorrhagic, thrombotic and infectious risks. Failure to assess these risks resul-ted in an error of omission. There was no limitation of the rehospitalization consequences. Anticoagulant, anti-aggregating medication was discontinued before and after surgery, determining conditions for venous thrombosis and thrombosis of the new stent – error of omission.

Main cause (root): Lack of patient safety culture due to lack of regulations regarding the introduction of a new diagnostic and therapeutic technique; lack of regulations for the assessment of professional competence.

Conclusions: The analyzed sentinel (catastrophic) event shows serious managerial deficiencies in organizational and clinical management. Deficiencies in organizational management: lack of regulations regarding the control at the implementation of new diagnostic and therapeutic techniques through a Medical Council approved protocol. Deficiencies in clinical management: lack of concern for maintaining and increasing the competence level and for evaluating compliance with diagnostic and therapeutical practice guidelines.


ISSN – online: 2734 – 6382
ISSN-L 1220-658X
ISSN – print: 1220-658X
The Romanian Journal of Cardiology is indexed by:
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CODE: 379
CME Credits: 10 (Romanian College of Physicians)
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