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

Catalog Number 1125225-12

Device Problems Peeled/Delaminated (1454); Product Quality Problem (1506); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that after pre-dilating a mildly calcified, concentric, 75% stenosed 10-mm-long lesion in the moderately tortuous 2.25mm diameter distal circumflex coronary artery with a 2.0mm non-abbott balloon catheter, a 2.25x12 xience alpine stent delivery system (sds) was advanced without force applied, but failed to cross the lesion due to patient anatomy.In order to perform additional dilatation with a balloon, the xience alpine was withdrawn from the anatomy, without resistance, when it was noted that there was shredding and flaring of the balloon material at the proximal part of the balloon.While no damage was noted to the stent struts and the stent remained firmly crimped on the balloon, the xience alpine was not used to complete the procedure due to the balloon shredding/flaring.Reportedly, the shredded balloon did not appear to have detached from the balloon inside of patient anatomy.Another 2.25x12 xience alpine sds was able to cross the lesion successfully and was deployed without issue, completing the procedure.There was no occurrence of a clinically significant delay and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis; however, there was no balloon material shredding and flaring noted at the proximal part of the balloon as reported but there was a foreign material on the proximal part of the balloon for a length of 2 mm confirming the reported unusual appearance.Additional follow-up confirmed that the correct complaint device had been returned and that the unidentified material is likely what was thought to be flared/peeled/shredded (balloon) material.A chemical analysis showed that the unidentified material to resemble hemoglobin and human skin.The reported unusual appearance 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5749536
• MDR Text Key: 48350580
• Report Number: 2024168-2016-04129
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2018
• Device Catalogue Number: 1125225-12
• Device Lot Number: 5022361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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