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

Model Number	1012531-60
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam and the reported activation failure were able 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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the interaction with the anatomy and/or inadvertent mishandling resulted in the noted multiple kinks on the stent sheath preventing the shaft lumens from moving freely; thus resulting in the reported/noted mechanical jam and the reported/noted activation/deployment failure.Manipulation of the device resulted in the noted device damages (partial outer member-stent sheath bond separation, multiple outer member splits) contributing to the reported difficulties.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 the procedure was to treat a lesion in the external iliac artery.The 9.0x60mm absolute pro self expanding stent system (ses) was advanced to the target lesion however difficulty was met with the thumbwheel and the stent would not deploy.The ses was removed and the procedure completed using an omnilink stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Return device analysis noted the outer member-stent sheath bond was partially separated.There were splits noted on the outer member proximal to the outer member-stent sheath bond area.The stent implant was exposed 6 mm from the distal end of the sheath.The distal sheath was retracted, 12 mm from the base of the tip.

• 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: 23606122
• Report Number: 2024168-2025-11660
• Device Sequence Number: 9918203
• Product Code: NIO
• UDI-Device Identifier: 08717648175794
• UDI-Public: (01)08717648175794(17)270731(10)4082261
• 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
• Report Date (Section B): 11/20/2025

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: 1012531-60
• Device Catalogue Number: 1012531-60
• Device Lot Number: 4082261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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
• Patient Sex: Unknown