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 07/07/2014

Event Type  Injury  

Event Description

Subsequent to the previous reports, the following information was received: on (b)(6) 2014, the patient was hospitalized and percutaneous transluminal angioplasty was performed in the right internal and common carotid artery, reducing stenosis from 80% to 30%.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial medwatch report, the following information was received: on (b)(6) 2014, the patient started experiencing non-serious intermittent left arm tingling, which they are attributing to pressure on their neck from their new furniture; however, since the stent is restenosed, the physician feels the relationship to the device is unknown.No treatment was provided and the condition is noted to be continuing.There was no additional information provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction, and the product was not returned.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The reported patient effect of neurological deficit/dysfunction is a known observed and potential patient effect as listed in the rx acculink 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.Based on the information reviewed, there is no indication of a product deficiency.

Event Description

It was reported that on (b)(6) 2012 a 6-8x30mm rx acculink was successfully implanted in the heavily calcified right internal carotid artery (rica), with post procedure stenosis of 40%.On (b)(6) 2014, per carotid angiogram, 80% in-stent restenosis was noted in the ostial rica and 50% stenosis in the ostial right external carotid artery.The event is noted as continuing with no reported plans for treatment.There was no additional information provided.

Manufacturer Narrative

(b)(4).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 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.

• 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: 3947231
• MDR Text Key: 5214662
• Report Number: 2024168-2014-04646
• 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: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2014
• 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: 1011343-30
• Device Lot Number: 2041861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2014
• 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: 70 YR
• Patient Weight: 115