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

Model Number	1012536-80
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a left external iliac artery to common femoral artery (cfa) occlusion.A 6.0x80mm supera stent was implanted in the cfa.An 8.0x80mm absolute pro self expanding stent system (ses) was advanced over a command 18 guide wire to be placed between the supera and the iliac leg of the abdominal aortic stent (external iliac artery segment).After the ses was delivered to the target lesion through the abdominal stent, the physician opened the lock and began rolling the release roller.After rolling continuously for 8-9 circles, no stent deployment was detected under imaging, and the thumbwheel stopped rolling; therefore, the ses was removed from the anatomy.After withdrawal, the ses re-entered the sheath along with the command18; however, resistance was noted.Upon careful examination of the image, it was discovered that the absolute stent was fully deployed within the previously deployed non-abbott abdominal main stent.The left superficial femoral artery (sfa) was punctured and a command 18 guide wire was passed through the stent and an attempt was made to use a 8x60mm armada 35 balloon dilatation catheter for dilatation.After fixing the stent, the absolute stent was dragged to the left common iliac artery.As the common iliac artery had already been implanted in the healthy iliac leg with a small inner diameter, the absolute stent could not be fully pulled back; therefore, a 14x60 protege gps stent was inserted from the left sfa, and the absolute stent distal end was pressed against the common iliac artery, while the proximal end was located in the abdominal aorta and was not treated.Finally, another 8x60 absolute stent was implanted in the iliac leg and supera stent (external iliac segment) to complete the surgery.There were no adverse patient sequela 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 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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that during deployment interaction of the device with the mildly calcified, mildly torturous, 80% stenosed anatomy in conjunction with inadequate support of the shaft due to use of an undersized guidewire prevented movement of the shaft lumens, thus resulting in the reported physical resistance / sticking thumbwheel; however this cannot be confirmed.The investigation determined a conclusive cause for the reported physical resistance / sticking difficulties cannot be determined.During removal/re-entry into the sheath/guiding catheter inadvertent interaction of the compromised device with the sheath/guiding catheter resulted in the absolute stent becoming fully deployed within the abdominal main stent; thus resulting in the reported difficult or delayed activation.The treatment appears to be related to the operational context of the procedure as reportedly a non-abbott stent was used to press the absolute stent distal end against the common iliac artery, while the proximal end was located in the abdominal aorta and was not treated.Additionally, the patient underwent an additional procedure, which was another 8x60 absolute stent implanted in the iliac leg and supera stent (external iliac segment).Reportedly, an.018¿ guide wire was used with the 6.0x80mm absolute pro self-expanding stent system (sess).It should be noted the absolute pro.035 peripheral self-expanding stent system instructions for use states: use a 0.035¿ (0.89 mm) diameter guide wire with the absolute pro.035 peripheral self-expanding stent system.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.In this case, it is unknown if use of an incorrect guidewire contributed to the reported difficulties.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: 24258591
• Report Number: 2024168-2026-00481
• Device Sequence Number: 8064919
• Product Code: NIO
• UDI-Device Identifier: 08717648176166
• UDI-Public: (01)08717648176166(17)280229(10)5032861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 1012536-80
• Device Catalogue Number: 1012536-80
• Device Lot Number: 5032861
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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: 6 X80 SUPERA STENT; COMMAND 18 GUIDE WIRE; XIANJIAN ABDOMINAL STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown