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

Model Number	1012535-100
Medical Device Problem Codes	Malposition of Device (2616); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device during the inspection prior to use, it is possible that interaction with the anatomy and/or other devices prevented the shaft lumens from moving freely resulting in the reported physical resistance - thumbwheel; however, this cannot be confirmed.The investigation determined a conclusive cause for the thumbwheel difficulties cannot be determined.Manipulation of the compromised device resulted in the stent being inadvertently implanted outside the target lesion and in healthy tissue (reported stent malposition of device).As reported, the patient was subject to undergo an additional procedure in which a non-abbott stent was deployed to crush the absolute pro ses against the vessel wall and to treat the bifurcated 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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left external iliac artery.During the deployment of a 7x100mm absolute pro self-expanding stent (ses) the thumbwheel was noted to lock resulting in the stent being implanted outside the target lesion and in healthy tissue.Therefore, the patient was subject to undergo an additional procedure on (b)(6) 2025, in which a non-abbott stent was deployed to crush the absolute pro ses against the vessel wall and to treat the bifurcated lesion.There were no adverse patient sequela nor clinical delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported thumbwheel physical resistance / sticking was able to be confirmed.The reported malposition of device 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 query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device during the inspection prior to use, it is likely that interaction with the anatomy and/or inadvertent mishandling resulted in the noted multiple stent sheath kinks; thus preventing the shaft lumens from moving freely resulting in the reported physical resistance-thumbwheel/noted mechanical jam.Manipulation of the compromised device resulted in the stent being inadvertently implanted outside the target lesion and in healthy tissue (reported stent malposition of device).As reported, the patient was subject to undergo an additional procedure in which a non-abbott stent was deployed to crush the absolute pro ses against the vessel wall and to treat the bifurcated 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.D9 correction - device available for evaluation updated.Subsequent to filing the previous report, the device was received for analysis.Therefore, d9 has been updated from no to yes.

• 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: 21595076
• Report Number: 2024168-2025-02617
• Device Sequence Number: 8925340
• Product Code: NIO
• UDI-Device Identifier: 08717648176098
• UDI-Public: (01)08717648176098(17)270531(10)4062461
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012535-100
• Device Catalogue Number: 1012535-100
• Device Lot Number: 4062461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American