MAUDE Adverse Event Report: ABBOTT VASCULAR ACCULINK; CAROTID STENT

Catalog Number 1010133-40

Device Problems Material Separation (1562); Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was received.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 a moderately calcified lesion in the moderately tortuous common carotid artery.An emboshield nav6 was placed in the left internal carotid artery without issue.An acculink stent was then advanced and released without issue; however, the lesion was not fully covered.Another 7x10x40 mm acculink stent was advanced without issue but there was difficulty deploying the device.The delivery system was removed and it was found that the stent had been deployed in the common carotid artery.It was attempted to remove the stent; however, it fractured and about 10 cm remained in the patient.The patient was sent for surgery to have the remaining portion removed.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported material separation was confirmed.The malposition of the device was not able to be confirmed as it was based on procedural circumstances.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 other incidents and/or complaints.The investigation determined that the reported difficulties were related to case circumstances.It is likely that interaction with the first implanted acculink stent contributed to the difficulty and caused the distal outer sheath to tear and separate.As a result, the stent deployed in the common carotid artery during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: b5 - event description; d7- explant date removed.

Event Description

Correction: the acculink stent implant did not separate, but was deployed and remains implanted in the common carotid artery.The acculink delivery system [shaft] separated and the 10 cm that remained in the patient was removed surgically.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: 9269337
• MDR Text Key: 164721637
• Report Number: 2024168-2019-13124
• Device Sequence Number: 1
• Product Code: NIM
• 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: 01/24/2020

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 1010133-40
• Device Lot Number: 9032761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD NAV6.; EMBOSHIELD NAV6
• Patient Outcome(s): Required Intervention