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

Catalog Number 1011338-30

Device Problem Break (1069)

Patient Problem Stenosis (2263)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat the left internal carotid artery that did not have any tortuosity or calcification.In-stent restenosis was noted via angiography in a 6.0 x 30 mm acculink ii stent that was previously implanted on (b)(6) 2013.The acculink stent was broken and there was restenosis in the fractured area of the stent and proximal to the stent.The restenosis was therefore treated with a 4.0 x 2.0 mm viatrac peripheral dilatation catheter that was used for pre-dilatation.Then an 8.0 x 6.0 x 30 mm xact stent was implanted in the broken part of the acculink stent.The xact stent was post-dilated with a 5.0 x 20 mm viatrac dilatation catheter at 14 atmospheres to successfully complete the procedure.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).The device was not returned for analysis.It may be possible that fatigue from artery dynamics and motion may contributed to the stent fracture; however, this could not be confirmed.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of restenosis is a known observed and potential patient effect as listed in the rx acculink, domestic, instructions for use.The investigation was unable to determine a cause for the reported stent fracture.The reported restenosis was due to case circumstances.There is no indication of a product quality issue with respect to manufacture, 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 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6824922
• MDR Text Key: 83833135
• Report Number: 2024168-2017-07002
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011338-30
• Device Lot Number: 1111651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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