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

Catalog Number 1011344-40

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

Patient Problem Stenosis (2263)

Event Date 04/03/2014

Event Type  Injury  

Event Description

Subsequent to the initial medwatch report, the following information was received: on (b)(6) 2015, the patient was admitted to the hospital.Another stent was implanted in the re-stenosed, left internal carotid artery stent.The re-stenosis resolved without sequela and on (b)(6) 2015 the patient was discharged from the hospital.There was no additional information provided.

Manufacturer Narrative

(b)(4).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.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

It was reported that on (b)(6) 2012, an acculink stent was implanted in the left internal carotid artery and the patient was discharged home on (b)(6) 2012.On (b)(6) 2014, during a follow-up visit, a carotid angiogram was performed showing 90% restenosis of the left internal common carotid at the distal stent portion.There was no treatment and no hospitalization.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.There was no reported device malfunction, and the product was not returned.The reported patient effect of stenosis is a known observed and potential patient effect as listed in the eifu, css, rx acculink, domestic, instructions for use (ifu).Although a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.

Manufacturer Narrative

(b)(4).

• 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: 3778660
• MDR Text Key: 5885940
• Report Number: 2024168-2014-02682
• 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,Followup,Followup
• Report Date: 04/04/2014

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: 03/31/2014
• Device Catalogue Number: 1011344-40
• Device Lot Number: 2041361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 04/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/29/2015; 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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 Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 78