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

Model Number	1012534-40
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis; however a photo provided by the account confirmed the reported premature activation.Production record and corrective and preventive 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 level product quality issue.It is possible that inadvertent mishandling while unpackaging the device caused the distal sheath to slightly retract from the base of the tip and inadvertently prematurely expose the stent; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.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 during the procedural preparation, the 6x40mm absolute pro self-expanding stent (ses) was partially deployed when pulled out of packaging; however, the stent struts were not flowered.Therefore another same sized absolute pro ses was used to complete the procedure.There was no patient involvement 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: 22639579
• Report Number: 2024168-2025-07820
• Device Sequence Number: 13146215
• Product Code: NIO
• UDI-Device Identifier: 08717648175985
• UDI-Public: (01)08717648175985(17)270831(10)4092561
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/28/2025

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 Model Number: 1012534-40
• Device Catalogue Number: 1012534-40
• Device Lot Number: 4092561
• 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: 07/08/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2024
• 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
• Patient Sex: Unknown