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

Catalog Number 1012534-100

Device Problems Material Separation (1562); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  Injury  

Event 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.

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 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
• 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: 18271449
• MDR Text Key: 329774301
• Report Number: 2024168-2023-13505
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176012
• UDI-Public: 08717648176012
• 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: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2023
• 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
• Treatment: 6F SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female