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

Catalog Number 1125350-28

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

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.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that after successful positioning of an unspecified guide wire in a lesion in an unspecified vessel, an attempt was made to advance a 3.5x28 rx xience alpine drug-eluting stent (des) system over the guide wire.Prior to entering patient anatomy, the xience alpine became stuck on the guide wire (unable to be advanced or retracted).This xience alpine never entered the anatomy.With slight force and maneuvering applied, the xience alpine des system was able to be retracted over the proximal end of the guide wire.Another xience alpine was able to be easily advanced over the same guide wire and was used to successfully treat the lesion.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported difficulty to position and the reported difficulty to remove were able to be confirmed.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6191902
• MDR Text Key: 63193864
• Report Number: 2024168-2016-09076
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: 1125350-28
• Device Lot Number: 6091541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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
• Patient Age: 56 YR