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

Model Number	1012536-40
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the right external iliac artery with moderate calcification, mild tortuosity and 80% stenosis.The lesion was pre-dilated with a non-abbott 8x40 mm balloon.The 8x40 mm absolute pro self expanding stent system (sess) was advanced to the lesion but the stent was getting stuck just outside the sheath.The device started to deploy the stent when it was being removed from the anatomy.The guide wire and sess were removed together as they were stuck together.A non-abbott device was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported premature activation and the reported difficult to remove were able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.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 interaction with the moderately calcified, mildly tortuous and 80% stenosed anatomy and/or inadvertent mishandling resulted in the noted stent sheath kink resulting in the reported difficult to advance and the reported difficult to remove.As the device was being removed it is likely that interaction with the sheath/guiding catheter resulted in causing the distal sheath to slightly retract from the base of the tip and inadvertently prematurely deploy the stent.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.B5: procedure description was updated.
Event or Problem Description
Subsequent to the initially filed report it was reported that the device became stuck during advancement just outside the sheath.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: 23649357
• Report Number: 2024168-2025-11762
• Device Sequence Number: 18655627
• Product Code: NIO
• UDI-Device Identifier: 08717648176142
• UDI-Public: (01)08717648176142(17)280731(10)5080461
• 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,Followup
• Report Date (Section B): 01/19/2026

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: 1012536-40
• Device Catalogue Number: 1012536-40
• Device Lot Number: 5080461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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: 035 J GUIDE WIRE.; 6FR 45 CM DESTINATION SHEATH.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White