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

Catalog Number 1125350-38

Device Problems Failure to Advance (2524); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: guide wire: runthrough nc, sion blue, guide catheter: hyperion 6fr jl3.5.Evaluation summary: (b)(4).The device was returned for analysis.The reported material deformation 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 quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.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 evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a de novo lesion located in the moderately calcified, mildly tortuous, 90% stenosed, proximal left anterior descending artery.The lesion diameter measured 2.25 x 15).After pre-dilatation was performed and the lesion checked via intravascular ultrasound (ivus), a 3.5 x 38 mm xience alpine stent delivery system (sds) was to the target lesion, but failed to cross.When the sds reached the proximal end of the target lesion during advancement, there was a strange feeling of passing through a rough surface, which was different from a feeling usually felt during advancement of sds or other devices.When the xience alpine 3.5 x 38 mm sds was removed from the patient anatomy, stent flaring was noted on the distal edge; however, there was no resistance noted during retraction.The device was replaced with another new xience alpine 3.5 x 38mm sds, which crossed the lesion without any issue and the stent was successfully implanted.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.Device analysis revealed a longitudinal tear in the distal part of the balloon and a tear in the outer member proximal to the guide wire exit notch.

• 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): CLONMEL, IRELAND REG# 9616693; 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: 5417962
• MDR Text Key: 37745818
• Report Number: 2024168-2016-00707
• 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
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2018
• Device Catalogue Number: 1125350-38
• Device Lot Number: 5050741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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