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

Catalog Number 1120250-28

Device Problems Leak/Splash (1354); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspections were performed with guide wire exit notch torn and a leak.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties of failure to advance, guide wire exit notch tearing and inner member tear appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion located in the proximal left anterior descending coronary artery that was moderately tortuous, moderately calcified and re-stenosed.The xience alpine 2.5 x 28 mm stent delivery system was advanced but could not cross the lesion due to a previously implanted stent from a prior angioplasty procedure in the vessel 10 years prior.Additional dilatation was performed but the stent failed to cross a second time for the same reason.A non-abbott 2.5 x 26 mm stent was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis revealed the inner and outer member were torn and jagged at the guide wire exit notch extended distally for a length of 1 mm.There was a leak at 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: 7448305
• MDR Text Key: 106300752
• Report Number: 2024168-2018-02942
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2020
• Device Catalogue Number: 1120250-28
• Device Lot Number: 7062841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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: 59 YR
• Patient Weight: 82