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

Model Number 1011339-40

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported that during device preparation of the.014 acculink self-expanding carotid stent system (sess), during removal of the protective stylet, the tip detached from the delivery system.The acculink was not used for the procedure.There was no patient involvement and no clinically significant delay in the procedure.A new stent was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis however the account provided video confirming the reported tip separation.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 from this lot.It is possible that inadvertent mishandling during removal of the protective stylet resulted in the reported tip separation; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

The device was returned for analysis.The reported material separation tip was able to be confirmed.Additionally the following was noted during returned device analysis: indented sheath edge, wrinkled sheath, stent moved distally 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 from this lot.It is possible that inadvertent mishandling during removal of the stylet resulted in the noted device damages (indented sheath edge, wrinkled sheath, stent moved distally) and ultimately resulted in the reported tip separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Type of Device: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16128132
• MDR Text Key: 306981719
• Report Number: 2024168-2023-00338
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648076268
• UDI-Public: 08717648076268
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P040012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1011339-40
• Device Catalogue Number: 1011339-40
• Device Lot Number: 1081261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2021
• 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