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

Catalog Number	1012535-80
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Defective Device (2588); Device Damaged by Another Device (2915); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a superficial femoral artery that is 100% stenosed.The vessel was pre-dilated with a 6.0x200mm armada 18 balloon at nominal pressure.The 7.0x80mm absolute pro self-expanding stent (ses) was implanted; however, when attempting to post dilate the stent, the unspecified balloon was advanced into the stent; however, the stent folded in on itself (accordion) and had to place a non abbott stent at the distal edge of the absolute pro to cover it.The delivery system was removed under fluoroscopy.There was no adverse patient sequela reported and no clinically significant delay reported.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.Reportedly, a.014 size guide wire was used.It should be noted the absolute pro vascular self-expanding stent system instructions for use (ifu) states: one 0.035" (0.89 mm) diameter guide wire.The deviation of the ifu does not appear to have contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that when attempting to post dilate the deployed absolute pro stent interaction between the balloon and the deployed absolute pro stent resulted in the reported difficult to advance.Interaction/manipulation resulted in the reported defective device-shortened (stent folded in on itself); thus ultimately resulting in the reported device damaged by another device.The treatment(s) appears to be related to the operational context of the procedure as another manufacturers stent was placed at the distal edge of the absolute pro to cover it.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 18103342
• Report Number: 2024168-2023-12475
• Device Sequence Number: 17567341
• Product Code: NIP
• UDI-Device Identifier: 08717648176081
• UDI-Public: 08717648176081
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/01/2023

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: 03/31/2026
• Device Catalogue Number: 1012535-80
• Device Lot Number: 3041861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Patient Race: Black Or African American