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

Catalog Number 1125250-18

Device Problems Collapse (1099); Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a trifurcation of the circumflex, obtuse marginal 1, and the obtuse marginal 2 arteries.A 2.5 x 18 mm xience alpine stent delivery system (sds) was being advance through a 6f guiding catheter with a 2.5 x 15 mm xience alpine sds for kissing balloon technique when there was resistance and the 2.5 x 18 xience alpine sds could not be advanced further because it became stuck with the other xience alpine sds.The 2.5 x 18 mm xience alpine was removed from the guiding catheter.After removal it was noted that the shaft of the stent delivery system felt rough and appeared damaged.Another 2.5 x 18 mm xience alpine sds was successfully used with the 2.5 x 15 mm xience alpine to 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).Concomitant products: guide wire: bmw, choice pt; guide cath: 6f boston scientific; stent: 2.5 x 15 xience alpine.Evaluation summary: the device was returned for analysis.The reported physical property issue and the reported collapse were able to be confirmed.The reported failure to position and the reported difficulty to remove the device were unable to be replicated in a testing environment as they were based on operational circumstances.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.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: 4571424
• MDR Text Key: 15106097
• Report Number: 2024168-2015-01193
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 1125250-18
• Device Lot Number: 4111061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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
• Patient Age: 63 YR