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 02/21/2014

Event Type  Injury  

Event Description

It was reported that an acculink stent was implanted in a left internal carotid artery (lica) and approximately 15 months later, at a follow up visit, during a cardiac assessment, there was 90% in-stent restenosis of the lica seen on the angiogram.There was no treatment or hospitalization reported.The event is listed as continuing.The physician plans to discuss with the patient regarding a medical treatment plan.There was no additional information provided.

Event Description

Subsequent to the initial medwatch report, additional information was received stating that on (b)(6) 2014 the patient was hospitalized again and there was a percutaneous coronary interventional (pci) procedure done on the target vessel/target lesion in the common carotid artery as treatment.The patient was discharged home on (b)(6) 2014.No additional information was 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.A similar incident query is not required as the complaint details and the lot history record review did not reveal a potential device issue related to the reported incident.Based on the information reviewed, there is no indication of a product deficiency.

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 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.

• 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: 3738614
• MDR Text Key: 4279233
• Report Number: 2024168-2014-02237
• 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
• Report Date: 03/18/2014

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: 11/30/2013
• Device Catalogue Number: 1011343-30
• Device Lot Number: 1120861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 04/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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: 94