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

Model Number	1012535-80
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was 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 deviation of the instructions for use as it is likely that use of the undersized 0.014¿ spartacore guide wire resulted in the noted stent sheath kink preventing the shaft lumens from moving freely thus resulting in the reported/noted activation failure.It should be noted the absolute pro self-expanding stent system instructions for use states: one (1) 0.035" (0.89 mm) diameter guide wire.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.As the deviation of the instructions for use likely caused/contributed to the reported difficulties an in-service letter to the physician will be required.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.H6 medical device problem code: 2017 - failure to follow steps / instructions.
Event or Problem Description
It was reported the procedure was to treat a lesion in the right iliac artery.The 7.0x80mm absolute pro self expanding stent system (ses) was advanced to the target lesion over a spartacore guide wire however during attempted deployment, the thumbwheel kept spinning and the stent was not able to be deployed.The ses was removed from the patient and a non-abbott stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Return device analysis noted the stent was exposed 5mm from the distal end of the sheath.

• 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: 23878682
• Report Number: 2024168-2025-12229
• Device Sequence Number: 17320038
• Product Code: NIO
• UDI-Device Identifier: 08717648176081
• UDI-Public: (01)08717648176081(17)271130(10)4120661
• 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): 12/23/2025

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: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 4120661
• 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: 12/17/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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