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

Catalog Number 1074225-23

Device Problems Unstable (1667); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The loose/mislocated stent was not confirmed.The failure to advance could not 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.The results of the query of similar incidents in the complaint handling database for this lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that the procedure was to treat a 90% stenosed, moderately calcified lesion in the mildly tortuous distal circumflex (cx) artery.Pre-dilatation was performed three times using a 1.75mm non-abbott balloon dilatation catheter (bdc).The 2.25x23mm xience xpedition stent delivery system (sds) failed to cross the lesion reportedly due to interactions with the patient's anatomy and was removed without reported issue.Upon withdrawal, the stent implant was noted to be slightly moved/shifted on the balloon, reportedly due to interactions with the calcification in the artery.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.Additional pre-dilatation was performed, and another 2.25x23mm xience xpedition sds was used to successfully complete the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• 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: 4606975
• MDR Text Key: 13453477
• Report Number: 2024168-2015-01430
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2016
• Device Catalogue Number: 1074225-23
• Device Lot Number: 4071741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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