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

Catalog Number 1011343-40

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

Patient Problems Atrial Tachycardia (1731); Stenosis (2263)

Event Date 03/13/2013

Event Type  Injury  

Event Description

It was reported that an acculink stent was implanted in a right internal carotid artery and the same day, the patient had a non-occlusive deep vein thrombosis (dvt) (ischemia) and supraventricular tachycardia (svt) (atrial tachycardia).Xarelto medication was given and both the dvt and svt resolved approximately one month later.Additionally, approximately 11 months after the index procedure, on (b)(6) 2014 there was in-stent restenosis found of the target lesion.The patient was hospitalized and an endarterectomy was done on (b)(6) 2014 and the implanted acculink stent was removed from the patients anatomy.Reportedly, the patient stopped her plavix 3 months prior.There was no additional information provided.

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the stent was returned for analysis.The reported patient effects could not be confirmed with the returned stent.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The stent implant was sent to the fluoroscopy lab for evaluation.The fluoroscopy image was review by a abbott vascular clinical specialist.The results note that there are two stents in the image; the larger stent is located in the common carotid.The second is in the internal carotid.At the location of overlap the stents are constricted.It appears that tissue and possibly calcium are restricting full stent expansion.There was no reported device malfunction.The reported patient effect of stenosis is a known observed and potential patient effects as listed in the rx acculink, domestic, instructions for use.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.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: 3778836
• MDR Text Key: 4360792
• Report Number: 2024168-2014-02690
• 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: 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: 05/31/2014
• Device Catalogue Number: 1011343-40
• Device Lot Number: 2060461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 04/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 86