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

Model Number	1012538-80
Medical Device Problem Codes	Break (1069); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, mildly tortuous iliac artery that is 85% stenosed.The artery was ballooned with an unspecified balloon and a 10x80mm absolute pro self-expanding stent was attempted to be deployed; however, the outer sheath of the stent fractured and the stent partially deployed.The device was removed and another stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production records 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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified, mildly tortuous, 85% stenosed anatomy resulted in the preventing the shaft lumens from moving freely resulting in the reported activation failure.Manipulation of the compromised device in attempt to deploy the stent resulted in a build-up of tension in the distal sheath ultimately resulting in the reported sheath break/fracture.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: corrected device available for evaluation from yes to no.
Additional Manufacturer Narrative
The device was returned for analysis.The reported break was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.Production records 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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified, mildly tortuous, 85% stenosed anatomy resulted in the preventing the shaft lumens from moving freely resulting in the reported activation failure.Manipulation of the compromised device in attempt to deploy the stent resulted in a build-up of tension in the distal sheath ultimately resulting in the reported sheath break/fracture and noted sheath material separation.Further manipulation of the compromised device during removal resulted in the noted kinked inner member.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, h3: correction updated device returning from yes to no h6: component code 4755 was removed.H6: type of investigation code 4114 was removed.H11: additional mfg narrative additional manufacturer narrative: revised.

• 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: 23598089
• Report Number: 2024168-2025-11608
• Device Sequence Number: 10380181
• Product Code: NIO
• UDI-Device Identifier: 08717648176302
• UDI-Public: (01)08717648176302(17)270831(10)4091961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 1012538-80
• Device Catalogue Number: 1012538-80
• Device Lot Number: 4091961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 02/12/2026; 04/09/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 03/05/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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
• Patient Sex: Unknown