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

Model Number	1012535-100
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	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017- failure to follow instructions.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified right superficial femoral artery (sfa) that is 70% stenosed.The absolute pro self-expanding stent system (sess) was deployed, but was very difficult to deploy as the thumbwheel was extremely difficult to roll.There were no adverse patient effects and no clinically significant delay.There as no additional information provided.
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.Reportedly, a.014 guide wire was noted to be used with the absolute pro.It should be noted the absolute pro self-expanding stent system instructions for use (ifu), materials required section 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 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 in conjunction with deviation of the ifu.It is likely that interaction with the moderately calcified and 70% stenosed anatomy in conjunction with use of the undersized 0.014¿ guide wire resulted in the noted multiple stent sheath kinks and the noted outer member splits preventing the shaft lumens from moving freely thus resulting in the reported thumbwheel physical resistance / sticking and the reported difficult or delayed activation.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: 23662666
• Report Number: 2024168-2025-11791
• Device Sequence Number: 9193493
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)280331(10)5042961
• 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): 12/22/2025

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: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 5042961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• 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 COOK ROADRUNNER
• Patient Sex: Unknown