MAUDE Adverse Event Report: ABBOTT VASCULAR INC. Absolute Pro; Stent, Iliac

Model Number	1012534-100
Medical Device Problem Codes	Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a de novo, moderately calcified superficial femoral artery lesion with 99% stenosis.A 6x100 mm absolute pro self-expanding stent was advanced along a 0.014 inch guide wire.However, during deployment, the wheel became stuck and was unable to roll.During removal, the stent became elongated and was deployed partially in healthy tissue and partially in the lesion.A new non-abbott stent was used to maintain the vessel and 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 difficult or delayed activation, stretched stent, and mechanical jam were unable to be replicated due to the condition of the returned device (stent previously deployed and not returned).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.Reportedly, a 6x100 mm absolute pro self-expanding stent was advanced along a 0.014-inch guide wire.However, during deployment, the wheel became stuck and was unable to roll.It should be noted the absolute pro self-expanding stent system instructions for use (ifu), materials required section 8.8.3 states: one (1) 0.035" (0.89 mm) diameter guide wire.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.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 deviation of the ifu and subsequent circumstances of the procedure as it is likely that use of the undersized 0.014 guide wire resulted in the multiple noted stent sheath kinks thus causing the device to become bent in the anatomy and preventing the shaft lumens from moving freely; ultimately resulting in the reported difficult or delayed activation and reported mechanical jam.Manipulation of the compromised device during removal resulted in the reported stretched stent.As reported, a new non-abbott stent was used to maintain the vessel and complete the procedure.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.

• Brand Name: Absolute Pro
• Common Device Name: Stent, Iliac
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50046150
• Report Number: 2024168-2026-02954
• Device Sequence Number: 9490813
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)270731(10)4080261
• 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
• Device Implanted Year: 2026
• 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): 07/27/2026

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: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 4080261
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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 Sex: Unknown