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

Catalog Number 1120300-33

Device Problems Stretched (1601); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported material deformation was confirmed.The reported failure to advance could not be replicated in a testing environment as it was related to operational circumstances of the procedure.Additionally, it was noted that there was stretching and bunching sporadically on the inner member and outer member (shaft) distal to the mid lap seal.All noted damage to the delivery system is likely due to handling and/or manipulation of the device during the procedure.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily calcified, heavily tortuous and 80% stenosed anatomy causing the reported failure to advance and subsequent material deformation.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat an 80% stenosed, heavily calcified and tortuous left anterior descending (lad) bifurcation and posterior diagonal branch.Due to the anatomy, two xience alpine stent delivery systems (3.0x33mm, 2.5x15mm) failed to cross, and there was damage noted to the struts.The stents were not implanted.There was no adverse patient effect or a clinically significant delay in procedure.The devices were received and the analysis revealed that the inner and outer shaft of the 3.0x33mm stent system was stretched.No additional information was provided.

• 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: 11120800
• MDR Text Key: 225336223
• Report Number: 2024168-2021-00106
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021

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 Expiration Date: 10/02/2022
• Device Catalogue Number: 1120300-33
• Device Lot Number: 9092641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1