MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

Catalog Number 1011340-40

Device Problems Premature Activation (1484); Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

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.

Event Description

It was reported that the procedure was performed to treat an eccentric de novo lesion in the left iliac artery with heavy tortuosity.An 8f guide catheter was placed and an unspecified 0.014 guide wire and non -abbott embolic protection system were advanced to the lesion.On advancement of an 8 x 40 mm acculink self expanding stent system (sess) with resistance from the anatomy, it was noted that the stent of the sess had partially deployed.The sess was removed and the stent completely deployed on passing through the unspecified hemostatic valve.The stent was simply manually removed and a new unspecified carotid wall stent was placed without difficulty to achieve good results.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual analysis was performed on the returned device.The reported premature deployment in the anatomy was not confirmed as the stent was returned undamaged and fully deployed.The failure to advance and difficulty removing was not able to be confirmed due to the condition of 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 identified no indication of a lot specific product quality issue.It should be noted that the rx acculink instruction for use (ifu) states that the device is indicated for the treatment of carotid artery stenosis in the internal carotid artery (ica).It could not be determined if the off-label use caused or contributed to the difficulties.The investigation determined that the reported difficulties were related to case circumstances.It is likely that anatomical conditions which were described as heavily tortuous contributed to the reported difficulties.It is likely that during the failed attempt to advance against resistance, the distal shaft became entrapped within the anatomy and the hypotube kinked.During removal into the introducer sheath, the separation of the distal shaft and hypotube likely occurred.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the 30-day initial medwatch report, the following information was received: on attempted removal of the 8 x 40 mm acculink self expanding stent system (sess), resistance with the guiding catheter was met and force was applied.The shaft of the sess separated.As the site of the separation was within the guide catheter, the distal portion of the sess was simply removed with the guide catheter as a single unit.No additional information was provided.

• Brand Name: ACCULINK
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8880839
• MDR Text Key: 154123859
• Report Number: 2024168-2019-10720
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076299
• UDI-Public: 08717648076299
• Combination Product (y/n): N
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1011340-40
• Device Lot Number: 9022661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.14 GUIDE WIRE; JR4 8 FR GUIDING CATHETER; SPIDER EMBOLIC PROTECTION SYSTEM