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 Problems Stenosis (2263); Thrombosis/Thrombus (4440)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event, relevant tests/laboratory data, treatment dates/therapy dates, implant date: dates are estimated.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute wall apposition include, but are not limited to, incorrect device size for lesion, patient anatomical morphology, and patient disease state.The reported patient effects of thrombosis and stenosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The reported patient effects appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Details are listed in the article, titled "difference of vascular healing between bioabsorbable-polymer and durable-polymer new generation drug-eluting stents: an optical coherence tomographic analysis" it was reported through a research article identifying xience alpine drug-eluting stents that may be related to the following: uncovered and malapposed stent struts which may influence the neointimal layer observed by optical coherence tomography (oct).The neointimal layer was possible smooth cell hyperplasia, neoatherosclerosis, or a layer of organized thrombus.

• 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: 11773907
• MDR Text Key: 249027928
• Report Number: 2024168-2021-03790
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/13/2021
• Initial Date FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR