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

Catalog Number 1125250-33

Device Problems Difficult to Remove (1528); Expulsion (2933); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2016

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: the device was returned for analysis.Visual and dimensional inspections were performed on the returned device.The stent dislodgement and stent damage were confirmed.The difficulty removing the protective sheath could not be replicated in a testing environment due to the condition of the returned device.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.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.The investigation was unable to determine a conclusive cause for the reported difficulties.

Event Description

It was reported that during preparation of a 2.50 x 33 mm xience alpine stent delivery system (sds), the protective sheath was stuck to the stent implant.While attempting to remove the protective sheath, the stent implant became dislodged from the balloon and the stent implant was stretched out.There was no reported patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 6042390
• MDR Text Key: 57925071
• Report Number: 2024168-2016-07093
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199202
• UDI-Public: (01)08717648199202(17)180524(10)5051841
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2018
• Device Catalogue Number: 1125250-33
• Device Lot Number: 5051841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• 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