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

Model Number	1012534-60
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam, activation failure and break 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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is likely that interaction with the moderately calcified anatomy in conjunction with use of the undersized 0.018¿ guide wire resulted in the noted device damages (multiple stent sheath kinks, inner member kink) preventing the shaft lumens from moving freely resulting in the reported/noted mechanical jam and the reported/noted activation failure.Interaction/manipulation of the compromised device during withdrawal resulted in the reported stent break/noted stent bent, stretched, broken struts and the noted outer member-stent sheath bond area partial separation.There is no indication of a product quality issue with respect to design, manufacture or labeling.H6 medical device problem code: 2017 - failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure performed was to treat a moderately calcified, superficial femoral artery.The 6.0x60mm absolute pro vascular self-expanding stent (ses) over a 0.018" guidewire, completely failed to deploy as the thumbwheel could not turn.The absolute pro vascular ses was withdrawn and the stent was noted to have broken stent struts.An unspecified device was used to complete the procedure.There were no adverse patient effects and no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.

• 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: 23783180
• Report Number: 2024168-2025-11993
• Device Sequence Number: 5129252
• Product Code: NIO
• UDI-Device Identifier: 08717648175992
• UDI-Public: (01)08717648175992(17)270831(10)4090361
• 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): 12/11/2025

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: 1012534-60
• Device Catalogue Number: 1012534-60
• Device Lot Number: 4090361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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 Age: 80 YR
• Patient Sex: Unknown
• Patient Weight: 73 KG