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

Catalog Number UNK RX ALPINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event has been estimated.The unique device identifier (udi) is unknown because the part and lot number were not provided date of implant has been estimated.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 investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute to wall apposition include, but are not limited to, incorrect device size for lesion, patient anatomical morphology, and patient disease state.There is no indication of a product quality issue with respect to manufacture, design or labeling.The adverse events referenced in are being filed under a separate medwatch report number.Attachment article, titled "comparison of 6-month vascular healing response after bioresorbable polymer versus durable polymer drug-eluting stent implantation in patients with acute coronary syndromes: a randomized serial optical coherence tomography study.".

Event Description

It was reported through a research article identifying xience alpine drug eluting stents (des) that were related to the following outcomes: malapposed struts, target lesion revascularization and in-stent restenosis.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of 6-month vascular healing response after bioresorbable polymer versus durable polymer drug-eluting stent implantation in patients with acute coronary syndromes: a randomized serial optical coherence tomography study.".

• Brand Name: XIENCE ALPINE 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: 12365768
• MDR Text Key: 269519056
• Report Number: 2024168-2021-07516
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• 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: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX ALPINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1