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

Catalog Number 1074225-15

Device Problems Detachment Of Device Component (1104); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a lesion located in the right coronary artery.During the attempt to cross the lesion with the 2.25x 15 mm xience xpedition, the proximal shaft of the sds separated.Another xience xpedition stent delivery system was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported shaft detachment was able to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.Based on a visual and dimensional 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 XPEDITION 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): CLONMEL, IRELAND REG# 9616693; 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: 4351646
• MDR Text Key: 5145519
• Report Number: 2024168-2014-08377
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 12/01/2014

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: 07/21/2016
• Device Catalogue Number: 1074225-15
• Device Lot Number: 4071641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 64 YR