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

Catalog Number 1120350-38

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2017

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: a visual inspection was performed on the returned device and it was noted the stent was not between the markers.The reported material deformation was able to be confirmed.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the electronic lot history record for the reported device revealed no associated nonconforming material records (ncmr).A query of the complaint handling database for the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported when attempting to insert 3.5x38mm rx xience alpine stent delivery system into an unspecified vessel, it was difficult to advance.When viewed under fluoroscopy, the stent was noted to be damaged.There were no reported adverse patient effects.No additional information was provided.The abbott vascular returned goods lab received the device with its stent implant stationary on the balloon but not between the markers.

• 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: 6358573
• MDR Text Key: 68515368
• Report Number: 2024168-2017-01527
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648205859
• UDI-Public: (01)08717648205859(17)191031(10)6101941
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1120350-38
• Device Lot Number: 6101941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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