MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number UNK XIENCE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Cardiogenic Shock (2262)

Event Date 03/19/2019

Event Type  Injury  

Manufacturer Narrative

Estimated date of event.Estimated date of implant.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of hypotension and ischemia are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported hypotension, ischemia, cardiac arrest and cardiogenic shock and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Literature title : predicted coronary occlusion and impella salvage during valve-in-valve transcatheter aortic valve replacement.

Event Description

It was reported that the procedure was to treat a left main lesion (lm).Heparinization was performed, and a guide catheter was placed in the lm.Then a guide wire was placed through the lm and positioned a bailout undeployed 3.5x18mm xience stent in the lm in case a possible occlusion were to occur.A temporary transvenous pacemaker was implanted in the right ventricle through the left femoral vein.A 26mm non-abbott stent was implanted during the valve-in-valve¿ transcatheter aortic valve (viv-tavr replacement) procedure.Shortly after the viv-tavr procedure, the closure of the lm ostium was observed and the patient presented profound hypotension, followed by ischemic cardiogenic shock and cardiorespiratory arrest in pulseless electrical activity rhythm.An immediate percutaneous coronary intervention of the lm was performed by deploying a 3.5x18mm xience stent previously positioned.After a few minutes of chest compressions and persistence of hemodynamic instability, an impella was implanted and another 4x12mm xience stent was implanted that extended to the aorta with angiographic success.Medication was provided.The patient recovered spontaneous circulation and after hemodynamic stabilization with vasoactive drugs, was transferred to the coronary intensive care unit, without major complications.The patient progressively improved hemodynamics, and thus was decannulated and all the vasoactive drugs and mechanical circulatory support system were weaned in the next day.The control echocardiogram after 3 days showed good valve function and normal myocardial contractility.The patient was discharged after 1 week without neurological or cardiac sequels.There was no adverse patient sequela or clinically significant delay.No additional information was provided.Details attached in article titled: "predicted coronary occlusion and impella salvage during valve-in-valve transcatheter aortic valve replacement".

• Brand Name: XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11262966
• MDR Text Key: 230024898
• Report Number: 2024168-2021-00770
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR