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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

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 reported patient effects of myocardial infarction, thrombosis, stenosis, and ischemia are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effect(s) of myocardial infarction, stenosis, ischemia and thrombosis, and the relationship to the product, if any, cannot be determined. However, the 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. Attachment: " biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with st-segment elevation myocardial infarction (biostemi): a single-blind, prospective, randomised superiority trial. ¿.

Event Description

It was reported through a research article identifying the xience xpedition and xience alpine that may be related to target lesion failure, defined as a composite of cardiac death, target vessel myocardial reinfarction (mi) (q wave and non q-wave), clinically indicated target lesion revascularization, ischemia, and stent thrombosis within 12 months of the index procedure. Specific patient information is documented as unknown. Details are listed in the attached article, titled: " biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with st-segment elevation myocardial infarction (biostemi): a single-blind, prospective, randomised superiority trial¿.

• 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: 9917398
• MDR Text Key: 189473254
• Report Number: 2024168-2020-03288
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK RX ALPINE
• 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

Patient Treatment Data

Date Received: 04/02/2020 Patient Sequence Number: 1