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

Model Number 1011343-40

Device Problems Break (1069); Loose or Intermittent Connection (1371)

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

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported loose or intermittent connection was unable to be confirmed due to the condition of the returned device; however there was a noted cracked flush port.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during preparation the syringe was over torqued during connection to the flush port of the device resulting in the noted longitudinal crack running across the entire length of the flush port; thus resulting in the reported loose or intermittent connection.The noted device damages (kinked/separated shaft, wrinkled sheath) likely occurred due to inadvertent mishandling or during packing for return analysis.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

It was reported that during preparation of a 6-8 x 40mm acculink self-expanding stent system (sess) that saline leaked out of the side of the flushing port where the syringe attaches.The syringe connection was confirmed and no cracks were observed on the sess.The sess was not used in the procedure and was replaced with another acculink sess.There was no patient involvement and no clinically significant delay reported in the procedure.Return device analysis found a break in the shaft (not in two pieces).The account reported they were not aware of the break.No additional information was provided.

• 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: 15433569
• MDR Text Key: 300318517
• Report Number: 2024168-2022-09787
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 2060261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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