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

Catalog Number	1012534-80
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional 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
• Common Device Name: 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
• Report Number: 2024168-2023-10825
• Device Sequence Number: 17564414
• Product Code: NIP
• UDI-Device Identifier: 08717648176005
• UDI-Public: 08717648176005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 1012534-80
• Device Lot Number: 3060861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown