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

Catalog Number 1120350-28

Device Problems Stretched (1601); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported failure to advance was based on operational circumstances and could not be tested.Additionally, the following was noted on the device: the balloon was tightly folded.The stent implant was stationary on the balloon between the markers.There were stretched, bent and mangled struts in the middle of the stent implant.There was a stretched strut at the proximal end of the stent implant.There were chatter marks on the outer member (om) proximal to the proximal seal.The inner and outer member were stretched distal to the guide wire exit notch.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported failure to advance appears to be related to the operational context of the procedure.In this case, it is likely the device interacted with the previously implanted stent during advancement resulting in the reported failure to advance.Further manipulation of the device in addition to interaction with the previously implanted stent during retraction likely contributed to the noted chatter marks on the outer member in addition to the stretched, bent and mangled stent struts and stretched inner/outer member.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly calcified, de novo, left anterior descending artery (lad).A 3.5x28mm xience alpine drug eluting stent (des) was unable to pass a previously deployed stent in the left-main artery (lm).After 20 minutes, the stent was withdrawn and a same sized, non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Return device analysis noted that the shaft 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: 11033667
• MDR Text Key: 225344444
• Report Number: 2024168-2020-10686
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2022
• Device Catalogue Number: 1120350-28
• Device Lot Number: 9050241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 95