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

Catalog Number UNK XIENCE V

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

Patient Problems Shock (2072); Tachycardia (2095); Stenosis (2263)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.The device was not returned for analysis.A review of the electronic lot history record (elhr) for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.The reported patient effects of stenosis and tachycardia 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 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.The xience prime stent referenced is filed under separate medwatch report number.

Event Description

It was reported that approximately 2 years ago, a 3.5x23mm xience v was implanted in the left anterior descending coronary artery (lad).On (b)(6) 2021, the patient presented in shock with ventricular tachycardia.The patient was treated with cardioversion and noradrenaline support and was awake.A coronary angiogram noted in-stent restenosis which was treated with a 3.5x23mm xience prime des.Post-dilatation was performed with a 4.0 nc balloon and blood flow was good with timi iii flow.The patient remained stable; however, approximately 20 minutes later, the patient vomited and experienced chest pain.Coronary angiogram noted that the vessel was 100% occluded with thrombus.The patient expired.No additional information was provided.

• 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: 12310829
• MDR Text Key: 266171830
• Report Number: 2024168-2021-07095
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK XIENCE V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention