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

Model Number	1012536-80
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
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 performed to treat a lesion in the internal iliac artery.A 8x80mm absolute pro self-expanding stent (ses) was advanced to the target lesion when the device felt "restricted" [resistance]; therefore, the ses could not be implanted.The device was difficult to remove so the decision was made to disassemble the handle and everything was removed as a single unit.There were no adverse patient effects nor clinical delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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, it is possible that interaction with the anatomy and/or other devices resulted in the reported failure to advance and the reported difficult to remove; however this cannot be confirmed.Additionally, it is possible that interaction with the anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in the reported activation/deployment failure.However this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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 initially filed report, the device was received and the return analysis revealed that the luer was separated and not returned, and a partial separation was noted at the outer member-stent sheath bond area.The account confirmed the correct device was returned; however could not provided information on if they were aware of the additional damages.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: 22460160
• Report Number: 2024168-2025-07040
• Device Sequence Number: 20970074
• Product Code: NIO
• UDI-Device Identifier: 08717648176166
• UDI-Public: (01)08717648176166(17)270731(10)4081961
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/08/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 4081961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown