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

Catalog Number 1011343-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 02/04/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2013, an acculink stent was successfully implanted in the right internal carotid artery.During a follow-up visit, the primary health care provider noted a bruit in the right carotid and on (b)(6) 2014, the carotid duplex noted a dramatic change.On (b)(6) 2014, the acculink stent was 90% re-stenosed and angioplasty was performed.That same day, the re-stenosis resolved without additional sequela.There was no additional information provided.

Manufacturer Narrative

(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other incidents for stenosis reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• 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: 3644358
• MDR Text Key: 22001374
• Report Number: 2024168-2014-01097
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: 1011343-30
• Device Lot Number: 3012461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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: EMBOLIC PROTECTION: EMBOSHIELD NAV6
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 56