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

Catalog Number 1011343-40

Device Problems Off-Label Use (1494); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Visual inspection was performed on the returned device.The separation was confirmed.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 of the reported lot revealed no other incidents.It should be noted that the rx acculink instruction for use states: the rx acculink carotid stent system, is indicated for the treatment of patients who require carotid revascularization.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the right superficial femoral artery.The 6-8x40mm acculink stent was deployed successfully at the lesion; however, during removal of the stent delivery system, it was noted that the distal shaft separated into two pieces.The separated portion of the device was simply removed.The patient remained stable.There was no resistance noted during advancement or withdrawal of the device and no force applied.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

• 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: 7779518
• MDR Text Key: 117003184
• Report Number: 2024168-2018-06232
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1011343-40
• Device Lot Number: 8011661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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