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

Model Number	1012536-20
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 8x20 mm absolute pro vascular self expanding stent system (sess) was being advanced onto a guide wire when the device became stuck to the guide wire prior to entering the sheath.When attempting to slide the device from the wire, there was resistance and the stent began to unsheathe and flower.A new absolute pro sess was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The absolute pro device is currently not commercially available in the us; however, it is similar to a device sold in the us.
Additional Manufacturer Narrative
The device was returned for analysis.The reported premature activation was able to be confirmed.The reported difficult to advance and difficult to remove were unable to be confirmed.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, and the reported difficult to advance and difficult to remove were unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a coagulation of blood and/or contrast on the guidewire resulted in preventing the device from moving freely and entering the introducer sheath, thus resulting in the reported difficult to advance and the reported difficult to remove.Manipulation of the compromised device resulted in causing the stent to slightly pull out of the sheath resulting in the premature 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: 24100122
• Report Number: 2024168-2026-00288
• Device Sequence Number: 10209905
• Product Code: NIO
• UDI-Device Identifier: 08717648176128
• UDI-Public: (01)08717648176128(17)260630(10)3072061
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 02/10/2026

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: 06/30/2026
• Device Model Number: 1012536-20
• Device Catalogue Number: 1012536-20
• Device Lot Number: 3072061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: 035 GLIDEWIRE ADVANTAGE.
• Patient Sex: Unknown