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

Model Number	1012535-100
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device was bent in the heavily calcified, heavily tortuous and 60-80% stenosed anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported activation/deployment failure.Manipulation of the compromised device resulted in the noted multiple stent sheath bunching and the noted inner member kink likely contributing to the reported difficulties.Interaction with the heavily calcified, heavily tortuous and 60-80% stenosed anatomy resulted in the reported difficult to remove.As reported, during removal the deployed stent was also pulled back and free-floating in the iliac artery.An unspecified stent was used to embed the absolute pro stent into the iliac artery.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 - incorrect prep.
Event or Problem Description
It was reported that the procedure performed was to treat a heavily calcified, heavily tortuous superficial femoral artery that is 60-80% stenosed.The 7.0x100mm absolute pro self-expanding stent (ses) was not prepped with the stylet in.When the absolute pro ses was deployed at the lesion, the stent could not be fully released.The absolute pro was disassembled in an attempt to release the stent, however, during removal of the absolute pro stent delivery system, resistance was met due to anatomy and the deployed stent was also pulled pack and free-floating in the iliac artery.An unspecified stent was used to embed the absolute pro stent into the iliac artery and a new absolute pro stent was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in 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: 22718338
• Report Number: 2024168-2025-08036
• Device Sequence Number: 9132604
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)260131(10)3021662
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/05/2025

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: 01/31/2026
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 3021662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 178 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White