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

Model Number	1012534-20
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified right superficial femoral artery.A csi device and unspecified balloon were used to prepare the lesion.Once at the lesion, the 6.0x20mm absolute pro vascular self-expanding stent system (sess) was advanced over a 0.014 non-abbott wire; however, during deployment, the stent did not flower initially, then jumped and fully deployed at an unintended location.A new 6.0x20mm absolute pro ses was deployed at the intended site to successfully complete the procedure.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 are no other complaints in this lot.Reportedly, the absolute pro vascular was advanced over a.014 guide wrie.It should be noted the absolute pro self-expanding stent system instructions for use (ifu), materials required section 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.The deviation of the ifu appears to have caused/contributed to the reported difficulties.Based on the information received, the investigation determined that the reported issues appears 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 in the moderately calcified anatomy resulted in a build-up of tension within the shaft lumens of the delivery system; thus resulting in a spring like release of the stent resulting in the reported malposition of device; thus resulting in the reported foreign body in the patient.Based on the 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 - failure to follow steps / instructions.

• 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: 24315352
• Report Number: 2024168-2026-00574
• Device Sequence Number: 5650660
• Product Code: NIO
• UDI-Device Identifier: 08717648175961
• UDI-Public: (01)08717648175961(17)270930(10)4101761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012534-20
• Device Catalogue Number: 1012534-20
• Device Lot Number: 4101761
• 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: 01/19/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2024
• 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: Other
• Patient Sex: Unknown