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

Model Number	1012535-100
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left proximal superficial femoral artery (sfa).The 7x100mm absolute pro self-expanding stent system (sess) was advanced to the target lesion, and the deployment system was unlocked; however, the thumbwheel would not turn and as a result the stent completely failed to deploy.Therefore, the sess was removed from the patient and during removal the stent was noted to be halfway out of the introducer sheath.Therefore, the sess and the introducer sheath had to be removed as a single unit.There were no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam, the reported stent material deformation/break, the reported difficult to remove and the reported deformation due to compressive stress were able to be confirmed.The reported activation failure(s) 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 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 anatomy and/or inadvertent mishandling resulted in the noted kinked stent sheath preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam.As the device was being removed interaction with the guiding catheter inadvertently resulted in the stent partially deploying into the guiding catheter; thus resulting in the reported activation failure and the reported difficult to remove.Manipulation of the compromised device resulted in the reported stent material deformation and reported stent break/noted stent implant 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.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that an armada balloon was additionally used in the same procedure without issue.At the target lesion, when attempting to deploy the 7x100mm absolute pro self-expanding stent, the thumbwheel slightly moved resulting in the stent becoming partially deployed.After, the thumbwheel would no longer rotate, and when the stent system was being removed, the stent became fully deployed introducer sheath.The stent was noted to become bent, stretched stent and have broken struts.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: 23909129
• Report Number: 2024168-2025-12254
• Device Sequence Number: 15740188
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)260731(10)3080461
• 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
• 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): 02/19/2026

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: 07/31/2026
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 3080461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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: 6X45MM DESTINATION INTRODUCER SHEATH.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Race: White