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

Catalog Number 1500350-38

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

Patient Problems Cardiac Arrest (1762); Perforation of Vessels (2135); Cardiac Tamponade (2226); Cardiogenic Shock (2262)

Event Date 07/20/2021

Event Type  Death  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the procedure was to treat the left main (lm) artery and left anterior descending artery (lad).A 3.5x38mm xience sierra stent was implanted in both lesions.Post dilatation with an unspecified device revealed a perforation in the lad and a rupture in the lm.A pericardial puncture was performed and a non-abbott covered stent was deployed at the lad as well as a non-abbott stent at the lm.Patient went into cardiac arrest; however, was recovered.The patient experienced cardiogenic shock and died.There was no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of death, perforation, cardiac arrest, shock and tamponade are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears 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.

• Brand Name: XIENCE SIERRA 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
• MDR Report Key: 12326274
• MDR Text Key: 266723488
• Report Number: 2024168-2021-07184
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

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 Expiration Date: 08/24/2023
• Device Catalogue Number: 1500350-38
• Device Lot Number: 0081241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2ND 3.5X38MM XIENCE SIERRA; 2ND 3.5X38MM XIENCE SIERRA
• Patient Outcome(s): Death