MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012534-80

Device Problems Difficult to Remove (1528); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/14/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the superficial femoral artery (sfa).The 6.0x80mm absolute pro vascular self-expanding stent system (sess) would not deploy completely and was stuck within the catheter.Thumbwheel became stuck and would not advance thus making it impossible to complete deployment of the stent.The stent system was removed through the sheath dragged to the common femoral artery (cfa) access site.Stent was pulled out and stuck in the sheath which caused delay in procedure and damage to access site.Surgical cutdown was performed to treat the damaged access site and prolonged hospitalization for access site healing.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

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 other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that during advancement the device was bent in the anatomy resulted in preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported mechanical jam and the reported activation failure.During removal of the compromised device interaction with the sheath resulted in the reported difficult to remove resulting in a delay in procedure and damage to access site.The treatment appears to be related to the operational context of the procedure as a surgical cutdown was performed to treat the damaged access site and prolonged hospitalization for access site healing.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9/h3 - device available for evaluation updated from ¿yes¿ to ¿no¿.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING 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: 17868577
• MDR Text Key: 324890757
• Report Number: 2024168-2023-10825
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176005
• UDI-Public: 08717648176005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• 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,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012534-80
• Device Lot Number: 3060861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention