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

Catalog Number 1074400-23

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Twisted/Bent (2981); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure of the non-tortuous, mildly calcified, posterior tibial artery, the xience xpedition stent delivery system failed to reach the lesion.During removal, without resistance, the shaft separated and the stent moved on the balloon.It was noted that the sheath was intentionally detached at the access site in order to remove the stent delivery system from the anatomy.Upon removal, it was noted that the distal shaft, from the guide wire exit notch to the mid lap joint, was stretched, torn and twisted.The procedure was completed using a second device without reported issue.There was no adverse patient effect or a clinically significant delay in procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: the device was returned for analysis.The shaft separation was able to be confirmed.The stent dislodgement was unable to be confirmed; however, the stent was noted to be mislocated on the balloon and follow up information confirmed the correct device was returned.The failure to advance and difficult to remove 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 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: 4583889
• MDR Text Key: 5452463
• Report Number: 2024168-2015-01286
• 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: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2015
• Device Catalogue Number: 1074400-23
• Device Lot Number: 3110541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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: 84 YR
• Patient Weight: 95