MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Model Number 1011343-40

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a heavily stenosed lesion, in the right common femoral artery, graft, with a very high bifurcation.During advancement of the 6-8x40 mm acculink self-expanding stent system (sess), resistance was felt with the anatomy and the distal shaft separated.Resistance was felt during withdrawal, requiring force.The separated segment was snared.A non-abbott stent was used to complete the procedure.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 complaints.It was reported that the device was being used to treat the right common femoral artery.It should be noted that the rx acculink instruction for use (ifu) states: the rx acculink carotid stent system is indicated for the treatment of patients who require carotid revascularization.Additionally, it was reported that resistance was felt with the anatomy and the distal shaft separated.The ifu, states: if resistance is met during delivery system introduction, the system should be withdrawn, and another system used.It could not be determined if the off-label use caused or contributed to the difficulties; however, it appears that advancing the rx acculink against resistance likely caused the shaft separation and subsequent difficulties.The investigation determined that the reported difficulties encountered were likely due to case related circumstances as well as user related.The resistance during advancement appears to be due to anatomical conditions.The difficulty removing and separation were likely due to advancing the rx acculink against resistance which likely caused the shaft (hypotube) to kink and separate resulting in difficulty removing and subsequent difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10112456
• MDR Text Key: 193591604
• Report Number: 2024168-2020-04683
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 9112661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention