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

Catalog Number	1012534-100
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).Using a 6fr sheath, the 6.0x100mm absolute pro stent was advanced to the target lesion and deployed; however, the stent was noted to have separated in two pieces.Therefore, a 6.0x60 mm absolute pro stent was advanced to be implanted between the gap of the broken stent; however, would not cross the implanted stent.The 6.0x100mm absolute pro stent remains in the patient not fully apposed to the vessel.The procedure was aborted.The patient is reported to be returning to the hospital in two weeks to attempt further treatment of the target lesion and broken stent.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 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 similar incidents from this lot.The reported stent material separation was able to be confirmed per the cine review.The reported difficult to advance and the reported difficult or delayed activation was unable to be replicated in a testing environment as they were based on operational circumstances.As there was no damage noted to the device during the inspection prior to use, it is possible that inadvertent mishandling during advancement and/or stent deployment resulted in the noted device damages (wrinkled sheath, cracked outer member, multiple outer member bends/kinks) thus resulting in the reported difficult or delayed activation and ultimately resulted in the reported stent material separation; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult or delayed activation and the reported stent material separation difficulties cannot be determined.The reported difficult to advance was a result of the attempt to implant the 6.0x60 mm absolute pro stent to be implanted between the gap of the broken/compromised deployed stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist: the media included does confirm that there is two pieces of stent material within the patient¿s sfa and there is a malfunction seen.I, however, cannot come to a conclusion of probable cause of the event after reviewing the complaint report and media associated with the report, as we do are not informed of: lesion morphology/characteristics, treatment algorithm prior to absolute pro 6.0x100mm delivery and confirmation that preparation and handling of device was per instructions for use (ifu).

• 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: 18271449
• Report Number: 2024168-2023-13505
• Device Sequence Number: 20808373
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/22/2024

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: 02/28/2026
• Device Catalogue Number: 1012534-100
• Device Lot Number: 3032461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female