MAUDE Adverse Event Report: AV-TEMECULA-CT RX ACCULINK CAROTID STENT SYSTEM

Catalog Number 1010129-40

Device Problems Difficult To Position (1467); Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported partial premature deployment and resistance with the guide catheter was unable to be confirmed as the stent was returned fully deployed.The investigation determined that the reported difficulties appear to be due to case 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 incidents from this lot.Based on visual analysis of the returned device and the reviewed information, there is no indication the issue was caused by or related to a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during a procedure to treat the distal common carotid artery, the acculink self expanding stent system met resistance with the non-abbott guide catheter and the stent prematurely, partially deployed in the guide catheter.There were no adverse patient effects.No additional information was provided.

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 additional relevant information.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4900079
• MDR Text Key: 13965921
• Report Number: 2024168-2015-03800
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 1010129-40
• Device Lot Number: 3111161
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: GUIDE CATHETER: TERUMO