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

Model Number	1012534-80
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the superficial femoral artery (sfa) with heavy calcification, mild tortuosity and 95% stenosis.The 6x80 mm absolute pro vascular self expanding stent system (sess) was advanced to the lesion via a command 18 guide wire.The device was attempted to be deployed; however, the thumbwheel would not rotate and the device completely failed to deploy the stent.A 6x80 mm absolute pro vascular sess was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the stent was partially deployed.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure and mechanical jam were able to be confirmed.Production record and corrective and preventative 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 deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that use of the undersized 0.018" command guide wire resulted in the device becoming bent in the heavily calcified, mildly torturous, and 95% stenosed anatomy, resulting in the noted multiple stent sheath kinks preventing the shaft lumens from moving freely; thus resulting in the reported/noted thumbwheel mechanical jam and the reported/noted activation/deployment failure.It should be noted the absolute pro.035 peripheral self-expanding stent system instructions for use states: use a 0.035¿ (0.89 mm) diameter guide wire with the absolute pro.035 peripheral self-expanding stent system.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.The deviation of the ifu appears to have caused/contributed to the reported difficulties.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.H6 medical device problem code: 2017 - failure to follow steps / instructions.

• 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: 24829968
• Report Number: 2024168-2026-01439
• Device Sequence Number: 16028596
• Product Code: NIO
• UDI-Device Identifier: 08717648176005
• UDI-Public: (01)08717648176005(17)270731(10)4081661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 4081661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• 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: COMMAND 18 GUIDE WIRE; MOUNTAIN SHAPED SHEATH
• Patient Sex: Unknown