MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ABSOLUTE PRO; STENT, ILIAC

Model Number	1012534-80
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal superficial femoral artery (sfa).The 6x100 abs pro vascular self-expanding stent system (sess) was advanced with resistance over a non-abbott 0.035 guide wire (gw); however, the sess was able to reach the target lesion.The stent was attempted to be deployed, but the thumbwheel was stuck and the stent completely failed to deploy.Therefore, the sess was removed from the patient and another 6x100mm abs pro was able to be advanced over the same gw and implanted without issue.Then, a 6x80mm abs pro sess was advance and intended to be implanted proximal to the previously implanted stent; however, the 6x80mm sess failed to cross the target lesion due to the anatomy and the sheath of the stent was noted to be stretched (broke).The 6x80mm sess was removed from the patient without issue and a non-abbott stent was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information.Return device analysis found the 6x100 abs pro stent implant was exposed 3 mm from the distal end of the sheath.The stent sheath was retracted 6 millimeters (mm) from the base of the tip.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.The reported sheath break was able to be confirmed as there was noted bunched sheath.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with the anatomy resulting in the reported failure to advance.Interaction and/or manipulation of the device resulted in the noted exposed stent, the noted bent/split tip and ultimately resulted in the reported broke sheath/noted bunched sheath.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional devices referenced in b5 are filed under separate medwatch report numbers.

• Brand Name: ABSOLUTE PRO
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 21735127
• Report Number: 2024168-2025-03312
• Device Sequence Number: 4007675
• Product Code: NIO
• UDI-Device Identifier: 08717648176005
• UDI-Public: (01)08717648176005(17)270228(10)4030161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/31/2025

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 Model Number: 1012534-80
• Device Catalogue Number: 1012534-80
• Device Lot Number: 4030161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: 0.035 COOK GUIDE WIRE; 6X100MM ABSOLUTE PRO VASCULAR STENT
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 78 KG