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

Model Number	1012534-100
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6 medical device problem code: 2017 - failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified left superior femoral artery (sfa).The 6.0x100mm absolute pro was advanced to the target lesion with some resistance felt with anatomy.When attempting to deploy the stent only partially deployed, the thumbwheel turned; however, did not deploy the rest the of the stent.Therefore, the physician pulled back the delivery system in order to deploy the rest of the stent and the stent deployed; however, the stent did fracture (separated into two).Therefore, a non-abbott stent was used to jail the absolute stent into the vessel wall.The guide wire used was a.018 unspecified guide wire.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis was performed on the returned device.The difficult activation, material separation could not be confirmed.The difficult to advance is related to the case conditions and cannot be replicated in a lab environment.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.It was reported an 018¿ guide wire was used to deliver the device.It should be noted that instructions for use (ifu) states, ¿the absolute pro utilizes a 0.035¿ (0.89 mm) guide wire.¿ it is unknown if the ifu violation contributed to the difficulties.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.It appears the difficult to advance and the shaft of the device kinked likely due to the reported calcification and/or the use of the 018¿ guide wire which prevented full retraction (difficult activation) of the sheath.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: 23223872
• Report Number: 2024168-2025-10937
• Device Sequence Number: 9509544
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)271130(10)4121861
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 11/26/2025

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 Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 4121861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 82 KG