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

Model Number	1012534-100
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified lesion in the superficial femoral artery (sfa).Access to the lesion was gained through a 6 fr sheath and a 6.0x100mm absolute pro self-expanding stent (ses) was successfully implanted with no noted issues.At this point, a 6.0x100mm absolute pro ses was advanced to the lesion over a.035 supra core guidewire through resistance with the anatomy; however during deployment the thumbwheel was noted to jam and the stent could only be partially deployed.Following this the physician decided, against the sales representative degression, to disassemble the handle and manually deploy the stent.Therefore the ses was left in the anatomy fully deployed and partially elongated in the sfa.There were no remedial actions performed and the procedure was completed.There were no adverse patient sequela nor clinical delay.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 similar incidents from this lot.Interaction with the moderately calcified anatomy resulted in the reported difficult to advance.As there was no damage noted to the device during the inspection prior to use, it is possible that the interaction with the moderately calcified anatomy prevented the shaft lumens from moving freely; thus resulting in the reported/noted mechanical jam and the reported/noted activation/deployment failure; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported mechanical jam and the reported activation failure cannot be determined.Manipulation of the compromised device by disassembling the handle and manually deploying the stent ultimately resulted in the reported stretched stent.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 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: 23295817
• Report Number: 2024168-2025-11117
• Device Sequence Number: 4889607
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)271130(10)4121861
• 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): 10/14/2025

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: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 4121861
• 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: 09/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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" SUPRACORE; SHEATH: 6FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown