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 Occlusion (1984); No Code Available (3191)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event, implant date: estimated dates.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number were not provided.The reported patient effect of occlusion is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment(s) 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 additional device malfunction referenced is being filed under a separate medwatch report#.Article, titled: a randomised comparison of healing response between the buma supreme stent and the xience stent at one-month and two-month follow-up: pioneer-ii oct randomised controlled trial.

Event Description

It was reported through a research article identifying unknown xience stents that may be related to the following: malposition, hyperplasia, obstruction, restenosis, and late lumen loss.Specific patient information is documented as unknown.Details are listed in the attached article, titled: a randomised comparison of healing response between the buma supreme stent and the xience stent at one-month and two-month follow-up: pioneer-ii oct randomised controlled trial.

• 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: 11266408
• MDR Text Key: 229854910
• Report Number: 2024168-2021-00790
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention