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

Model Number	1012534-100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the left distal superficial femoral artery (sfa) with moderate calcification.An orbital atherectomy device from another manufacturer would not turn on or run and the 6x100 mm absolute pro self expanding stent system (sess) did not fully deploy the stent.The devices were replaced and the procedure was completed.There were no adverse patient effects and there was no clinically significant delay in the procedure.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.
Event or Problem Description
It was reported that the procedure was to treat the left distal superficial femoral artery (sfa) with moderate calcification.An orbital atherectomy device from another manufacturer would not turn on or run and the 6x100 mm absolute pro self expanding stent system (sess) did not fully deploy the stent.The devices were replaced and the procedure was completed.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.Oa: it was reported the stealth 360 peripheral orbital atherectomy device (oad) was being used in an attempt to treat a 50% calcified left distal superficial femoral artery (sfa), however, the oad would not power on or spin.It was also indicated the 6x100 mm absolute pro self expanding stent system (sess) would not fully deploy.There were no patient complications as a result of the event.The devices were replaced and the procedure was completed.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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 50% calcified anatomy resulting in the noted multiple stent sheath kinks preventing the shaft lumens from moving freely; thus resulting in the reported activation/deployment failure.Manipulation of the compromised device resulted in the noted outer member-stent sheath bond area partial separation likely contributing to the reported difficulties.Further manipulation of the compromised device during removal likely resulted in the noted stent damages (bent/stretched/broken struts).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.

• 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: 22089310
• Report Number: 2024168-2025-05373
• Device Sequence Number: 20564509
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)250731(10)2080361
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/08/2025

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 Expiration Date: 07/31/2025
• Device Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 2080361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND GUIDE WIRE.
• Patient Sex: Unknown