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

Catalog Number 1074350-38

Device Problems Break (1069); Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.The reported difficulty to position and the reported difficulty to insert the device were unable to be replicated in a testing environment due to the condition of the returned device.In addition, the inner member was separated.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 of the complaint database revealed no other similar incidents reported for difficult to insert or difficult to position from this lot.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that during a procedure of the left anterior descending (lad) artery while attempting to insert and advance the 3.5 x 38 mm xience xpedition stent delivery system (sds) met resistance over the unspecified guide wire and it could not be advanced.There was no patient interaction.The device was removed and replaced with a same size xience xpedition sds and the procedure was continued without reported issue.There was no reported issue with device preparation outside the anatomy or protective sheath removal from the balloon/device.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed that the inner member is separated distal to the guide wire exit notch, but the outer member is intact.

• 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: 4207637
• MDR Text Key: 19369582
• Report Number: 2024168-2014-07058
• 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: 10/06/2014

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: 04/14/2016
• Device Catalogue Number: 1074350-38
• Device Lot Number: 4040941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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