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

Catalog Number UNK RX XIENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2011

Event Type  malfunction  

Manufacturer Narrative

Event estimated dates. The device was not returned as the stent remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The patient effects of death and serious injury referenced are being filed under separate medwatch reports. Literature attachment, title: long-term clinical outcomes of late stent malapposition detected by optical coherence tomography after drug-eluting stent implantation.

Event Description

It was reported through a research article identifying xience v stents that may be related to death, serious injury, and stent malapposition. Specific patient information is documented as unknown. Details are listed in the attached article, titled, long-term clinical outcomes of late stent malapposition detected by optical coherence tomography after drug-eluting stent implantation.

• Brand Name: XIENCE V 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: 9833105
• MDR Text Key: 183481819
• Report Number: 2024168-2020-02438
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: KS
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK RX XIENCE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial