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

Model Number	1012534-40
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported stretched stent was able to be confirmed.The reported premature activation and difficult to remove from the rhv were unable to be replicated in a testing environment due to the condition of the returned device (stent returned fully 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 inadvertent mishandling during preparation resulted in the noted stent sheath kinks causing the stent to inadvertently slightly pull out of its sheath; thus resulting in the premature activation of the stent.It is likely that advancement of the compromised device caused the stent to become lodged in the sheath valve, resulting in the reported difficult to remove rhv; further manipulation of the compromised device ultimately resulted in the reported/noted stretched stent.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
It was reported that the procedure was to treat a lesion in the proximal superficial femoral artery (sfa).The 6x40mm absolute pro self-expanding stent system (sess) was prepped successfully and loaded onto the guide wire, prior to entering the sheath, the distal end of the stent was observed to be protruding.Although the locking mechanism remained engaged, the stent became lodged in the sheath valve, resulting in the stent to become elongated and detached from the delivery system.The device was not implanted and was replaced with a new sess, allowing the procedure to be completed successfully.There was no adverse patient effects and no clinically significant delay was reported.No other 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: 24524302
• Report Number: 2024168-2026-00922
• Device Sequence Number: 9746564
• Product Code: NIO
• UDI-Device Identifier: 08717648175985
• UDI-Public: (01)08717648175985(17)280930(10)5100261
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/05/2026

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: 1012534-40
• Device Catalogue Number: 1012534-40
• Device Lot Number: 5100261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2025
• 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
• Patient Sex: Unknown