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

Model Number	1012534-100
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left superficial femoral artery (sfa) with no tortuosity.The 6x100mm abs pro vascular self-expanding stent system (sess) was advanced on a 0.14 viper guide wire (gw) through a 6f sheath to the target lesion; however, the thumbwheel would not turn and as a result the stent completely failed to deploy.The sess was removed from the patient.Another same size abs pro vascular sess was advanced on the same gw with the same sheath.During deployment of the second sess, the thumbwheel was sticking and difficult to turn; however, the stent was ultimately able to be deployed.There was no adverse patient effect and no clinically significant delay reported 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.H6: device code 2017 - failure to follow steps/instructions was added due to the guide wire selection.
Additional Manufacturer Narrative
The device was returned for analysis.The reported physical resistance / sticking and the reported difficult or delayed activation were unable to be replicated in a testing environment due to the condition of the returned device (stent previously deployed).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 deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that use of the undersized 0.014¿ guide wire resulted in the noted multiple stent sheath kinks preventing the shaft lumens from moving freely; thus resulting in the reported physical resistance / sticking and the reported difficult or delayed activation.It should be noted the absolute pro self-expanding stent system instructions for use states: one (1) 0.035" (0.89 mm) diameter guide wire.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.As the deviation of the instructions for use likely caused/contributed to the reported difficulties an in-service letter to the physician will be required.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: 24000411
• Report Number: 2024168-2026-00146
• Device Sequence Number: 10530897
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)260228(10)3032461
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/03/2026

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 Expiration Date: 02/28/2026
• Device Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 3032461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: .014 VIPER GUIDE WIRE.; 6F SHEATH.
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White