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

Model Number	1012531-60
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Difficult to Remove (1528); Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified and tortuous lesion in the iliac artery.A 9x60mm absolute pro self-expanding stent (ses) was attempted to be deployed over a.035" non-abbott guidewire and through a 7f non-abbott sheath; however the ses was noted to partially fail to deploy due to a mechanical jam with the thumbwheel, and the delivery catheter [shaft] was noted to crack.The ses was attempted to be withdrawn, but after resistance was felt with the sheath the stent was inadvertently deployed and separated inside the anatomy.The smaller portion of the separated stent was noted to migrate to the lower aorta in which a non-abbott stent was deployed to embed the stent to the vessel well.The larger portion of the separated stent was noted to migrate to the common iliac artery where a 10mm absolute pro was deployed to embed the stent to the vessel wall adn treat the target lesion a clinical delay was noted and there were no adverse patient sequela reported.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.
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 interaction with the mildly calcified and tortuous anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam and the reported activation/deployment failure.Interaction/manipulation of the device resulted in the reported shaft break/crack contributing to the reported difficulties.During removal inadvertent interaction with the sheath resulted in the reported difficult to remove, the reported stent premature activation and ultimately resulted in the reported stent material separations.As reported, a non-abbott stent was deployed to embed the smaller portion of the separated stent to the vessel wall and a 10mm absolute pro was deployed to embed the larger portion of the separated stent to the vessel wall and to treat the target lesion.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: 22347232
• Report Number: 2024168-2025-06597
• Device Sequence Number: 4825389
• Product Code: NIO
• UDI-Device Identifier: 08717648175794
• UDI-Public: (01)08717648175794(17)251231(10)3012461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/29/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 1012531-60
• Device Catalogue Number: 1012531-60
• Device Lot Number: 3012461
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2023
• 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: GUIDEWIRE: .035 GLIDE WIRE STIFF; SHEATH: 7F TERUMO PINNACLE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female