MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1125275-38

Device Problems Difficult to Remove (1528); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a mildly tortuous and mildly calcified left anterior descending artery.A 2.75 x 38 mm xience alpine stent delivery system (sds) was advanced past the diagonal in the lad.A 2.75 x 12 mm xience alpine stent was implanted in the diagonal with a portion extending into the lad.The 2.75 x 38 mm sds was being pulled back to perform a mini crush of the 2.75 x 12 mm xience alpine when the proximal end of the stent caught on the edge of the diagonal and the stent moved on the balloon.When removing the device it could not be pulled into the guiding catheter so the guiding catheter, sds and guide wire were removed as a single unit.The same guide wire and guiding catheter were re-positioned and a new 2.75 x 38 mm xience alpine was successfully deployed for the mini crush technique.A 3.0 x 23 mm xience alpine was implanted proximal to the 2.75 x 38 mm xience alpine to successfully complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The loose stent was unable to be confirmed as the stent was dislodged from the balloon.The difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.Based on a visual inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances.A query/review of the electronic complaint database revealed no other similar incidents reported for difficult to remove or loose stent from this lot.Based on the reviewed information, no product deficiency was identified.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4369710
• MDR Text Key: 5115231
• Report Number: 2024168-2014-08542
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2017
• Device Catalogue Number: 1125275-38
• Device Lot Number: 4092361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STENT: XIENCE ALPINE
• Patient Age: 63 YR
• Patient Weight: 92