MAUDE Adverse Event Report: ABBOTT VASCULAR XACT CAROTID STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 82098-01

Device Problem Premature Activation (1484)

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

Event Date 05/21/2023

Event Type  malfunction  

Event Description

It was reported that the 10x30x136 xact stent system was removed packaging and noted the tip of the stent was exposed.Another xact stent was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.Per device analysis the tip of stent was noted to be exposed; however, not flowered.The account confirmed this is correct.

Manufacturer Narrative

The device was returned for analysis.The reported premature activation was able to be 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 other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling/inadvertently rotating the deployment handle clockwise while unpackaging the device caused the sheath to slightly retract thus resulting in the stent to be partially exposed resulting in the reported premature activation.The noted sheath kink likely occurred due to handling during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XACT CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• 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: 17384064
• MDR Text Key: 319625441
• Report Number: 2024168-2023-07915
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08717648010347
• UDI-Public: 08717648010347
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P040038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82098-01
• Device Lot Number: 2101061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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