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

Model Number	1012532-100
Medical Device Problem Codes	Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.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 device was difficult to advance due to the guide wire not being wet enough.During stent deployment it is likely that interaction with the mildly calcified and 75% stenosed anatomy resulted in preventing the shaft lumens from moving freely resulting in the reported mechanical jam and the reported activation/deployment difficulties and resulting in the stent not becoming fully released from the system; thus during device removal resulted in the stent inadvertently becoming pulled back into the sheath and removed.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 that the procedure was to treat a mildly calcified superficial femoral artery that is 75% stenosed.During advancement of 10x100mm absolute pro self-expanding stent system resistance was felt with a.035 unspecified guide wire as the guide wire was not wet enough.When attempting to deploy the stent the thumbwheel was note to be difficult to turn; however, the stent was deployed.When attempting to remove the stent delivery system it was observed that the stent was being pulled back, which 80% of the stent was pulled back in the sheath and removed.Another same size absolute pro was used to successfully complete the procedure.There was 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: 23078535
• Report Number: 2024168-2025-09934
• Device Sequence Number: 17385007
• Product Code: NIO
• UDI-Device Identifier: 08717648175879
• UDI-Public: (01)08717648175879(17)260930(10)3100462
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 09/17/2025

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 Expiration Date: 09/30/2026
• Device Model Number: 1012532-100
• Device Catalogue Number: 1012532-100
• Device Lot Number: 3100462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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
• Patient Sex: Unknown