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

Catalog Number 1120350-23

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 during a procedure of the moderately calcified, diagonal artery ostium lesion, the xience alpine stent was implanted, not fully in the lesion, because the balloon marker was mislocated.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Internal file number - 326052/1-2.Evaluation summary: the device was returned for analysis.The reported device misassembled during manufacturing or shipping/marker band mislocation was unable to be confirmed.The reported difficult to position 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 identified no other similar incidents from this lot.The reported device misassembled during manufacturing or shipping/marker band mislocation was unable to be confirmed as both balloon marker band locations were within manufacturing specifications, and the investigation determined the reported difficult to position appears to be related to circumstances of the procedure as it is likely that the location of the proximal balloon marker band within the balloon working length contributed to the reported stent implanted not fully in the lesion.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Additionally, it was reported that no intervention was performed and the patient outcome was good.

• 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: 6767558
• MDR Text Key: 81977276
• Report Number: 2024168-2017-06422
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 1120350-23
• Device Lot Number: 5102141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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
• Patient Age: 44 YR
• Patient Weight: 86