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

Catalog Number 1010132-40

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was performed to treat an 80% stenosed lesion in the mid internal carotid artery with mild tortuosity and moderate calcification.During deployment of the 6-8/40 acculink stent, the stent jumped 70% outside the lesion; therefore, another acculink stent was deployed to cover the lesion and the patient had a good outcome.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for analysis.The difficulty deploying the stent was not able to be confirmed as the stent had already been deployed.Based on a visual inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that a definitive cause for the reported difficulties could not be determined.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

• 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: 4949951
• MDR Text Key: 6257473
• Report Number: 2024168-2015-04225
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor,company represent
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 1010132-40
• Device Lot Number: 4040761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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