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

Catalog Number 1010133-40

Device Problems Positioning Failure (1158); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and confirmed the reported partial deployment.A query of the complaint-handling database indicated that one additional event has been received for deployment difficulties from this lot.Although an expanded records review found no non-conforming material reports, the potential for a product deficiency does exist.Continued assessment of this issue per site operating procedures is being performed, corrective and preventive actions will addressed per quality system protocol.

Event Description

It was reported that using a femoral artery access approach during a narrow, 80% stenosed, below the bifurcation lesion of the internal carotid artery, the 10/40 mm acculink stent delivery system (sds) was positioned and the handle unlocked and stent deployment attempted; resistance was met with the handle and it could hardly move.After several unsuccessful attempts the undeployed stent and sds were removed from the anatomy without reported issue.A second acculink stent was used in the procedure without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).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: 3591779
• MDR Text Key: 11703538
• Report Number: 2024168-2014-00415
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 1010133-40
• Device Lot Number: 3030761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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