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

Model Number	1012534-100
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and the reported mechanical jam were able to be confirmed.The reported difficult to advance was unable to be confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.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 the device was bent in the anatomy resulting in the reported difficult to advance.Further interaction with the anatomy and/or inadvertent mishandling resulted in the noted multiple kinks on the stent sheath preventing the shaft lumens from moving freely; thus resulting in the reported/noted mechanical jam and the reported/noted activation/deployment failure; resulting in the noted stent implant exposed 3 mm from the distal end of the 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.
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 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.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.

• 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: 21732488
• Report Number: 2024168-2025-03252
• Device Sequence Number: 15652891
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(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: Other
• 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: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 4030161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 78 KG