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

Model Number	1012529-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superficial femoral artery (sfa) with heavy calcification and mild tortuosity.During advancement of the 7.00x100mm absolute pro self-expanding stent system (sess), without resistance, the catheter of the sess separated into 3 pieces.The sess stayed on the wire and was able to be removed as a single unit; however, resistance was noted with the slender 6fr guide catheter during removal.There was no adverse patient effect and no clinically significant delay reported in the procedure.A same size absolute pro with a less slender 6fr guide catheter was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was unable to be confirmed however there was a noted stabilizer/jacket separation.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.The stent implant was not returned.Additonally, the following was noted during device analysis: bunched with bends and separated stabilizer/jacket, wrinkled sheath, multiple distal sheath, i-beam, inner member, outer member bends 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 inadvertent mishandling resulted in the reported material separation/noted bunched/separated stabilizer/jacket and the noted device damages (wrinkled sheath, multiple distal sheath, i-beam, inner member, outer member and stabilizer/jacket bends; thus, resulting in the reported difficult to remove; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.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: 16287407
• Report Number: 2024168-2023-01102
• Device Sequence Number: 20065981
• Product Code: NIP
• UDI-Device Identifier: 08717648175657
• UDI-Public: 08717648175657
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 1012529-100
• Device Catalogue Number: 1012529-100
• Device Lot Number: 2102661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG