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

Model Number	1012532-40
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	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported physical resistance / sticking thumbwheel 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 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 circumstances of the procedure as it is likely that interaction with the moderately tortuous anatomy and the steep aortic bifurcation and/or manipulation of the device resulted in the noted multiple stent sheath kinks and the noted multiple chatter marks sporadically on the entire length of the inner member; thus resulting in preventing the shaft lumens from moving freely resulting in the reported/noted thumbwheel physical resistance / sticking and the reported difficult or delayed activation.Manipulation of the device likely resulted in the noted bent jacket contributing to the reported difficulties.Reportedly, the 10x40 mm absolute pro self-expanding stent system (sess) was advanced to the lesion and upon deployment the thumbwheel was difficult to roll.The stent was implanted after both hands were forcefully used to deploy the stent.It should be noted the absolute pro vascular self-expanding stent system instructions for use states: should unusual resistance be felt at any time, including resistance unlocking the handle or thumbwheel rotation, during either lesion access or stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment, or deployment in an unintended location.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: against resistance.
Event or Problem Description
It was reported that the procedure was to treat the left external iliac artery via right common femoral access.There was moderate tortuosity and a steep aortic bifurcation.The lesion was pre-dilated with a 6x40 armada 35 percutaneous transluminal angioplasty (pta) catheter.The 10x40 mm absolute pro self expanding stent system (sess) was advanced to the lesion and upon deployment the thumbwheel was difficult to roll.The stent was implanted after both hands were forcefully used to deploy the stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.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: 23292094
• Report Number: 2024168-2025-11087
• Device Sequence Number: 13310220
• Product Code: NIO
• UDI-Device Identifier: 08717648175848
• UDI-Public: (01)08717648175848(17)280331(10)5042261
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 10/14/2025

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: 1012532-40
• Device Catalogue Number: 1012532-40
• Device Lot Number: 5042261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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: 035 GLIDEWIRE ADVANTAGE
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White