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

Model Number	1012538-100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a calcified external iliac artery lesion.A 10x100 mm absolute pro self expanding stent system (ses) was advanced to the target lesion however the sheath was unable to be retracted and the stent could not be deployed.The ses was removed and another same size absolute pro ses was advanced to the target lesion however the stent was only able to deploy a third of the way.The ses with the stent was removed and the procedure completed using a non-abbott stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.Analysis of the first returned device indicated that the stent implant was exposed 2mm from the distal end of the sheath.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was able to be confirmed.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.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 circumstances of the procedure as it is likely that interaction with the anatomy resulted in the noted multiple stent sheath kinks preventing the shaft lumens from moving freely, resulting in the stent deploying only 1/3 of the way, ultimately resulting in the noted mechanical jam and the reported/noted activation/deployment failure.Further manipulation of the compromised device during removal likely resulted in the noted device damages (bent outer member, partial separation of outer member¿stent sheath bond area).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.The additional device referenced in b5 is being filed under a separate medwatch report number.

• 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: 24899812
• Report Number: 2024168-2026-01579
• Device Sequence Number: 18357664
• Product Code: NIO
• UDI-Device Identifier: 08717648176319
• UDI-Public: (01)08717648176319(17)270831(10)4090961
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012538-100
• Device Catalogue Number: 1012538-100
• Device Lot Number: 4090961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: .035 MERIT J WIRE
• Patient Sex: Unknown