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

Model Number	1012534-40
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
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 interaction with the heavily calcified anatomy resulted in the reported stent material separation; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported stent material separation cannot be determined.The treatment appears to be related to the operational context of the procedure as reportedly a non-abbott stent was deployed to secure the fractured stent against the arterial wall.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.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the common femoral artery.A 6x40mm absolute pro self-expanding stent (ses) was deployed at the target lesion; however, a fracture [separation] in the stent was noted.A non-abbott stent was deployed to secure the fractured stent against the arterial well, and the procedure was completed.There were no adverse patient effects 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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that interaction with the heavily calcified anatomy resulted in the reported stent material separation; however, this cannot be confirmed.The investigation determined a conclusive cause for the reported stent material separation cannot be determined.The treatment appears to be related to the operational context of the procedure as reportedly a non-abbott stent was deployed to secure the fractured stent against the arterial wall.Additionally, the patient underwent an additional procedure, which included relining the fractured and embedded 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.B2 - outcomes attributed to ae: hospitalization-initial or prolonged was added.H6 - health effect - impact code 4607 was added.Attachment: user facility medwatch report.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the common femoral artery.A 6x40mm absolute pro self-expanding stent (ses) was deployed at the target lesion; however, a fracture [separation] in the stent was noted.A non-abbott stent was deployed to secure the fractured stent against the arterial well, and the procedure was completed.There were no adverse patient effects nor clinical delay.Subsequent to the initially filed report, additional information was received stating the index procedure took place on (b)(6)2025.The patient was admitted for further monitoring and management.On (b)(6)2025, the patient underwent an additional procedure, to include relining the fractured and migrated stent.No additional information was provided.

• 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: 21326870
• Report Number: 2024168-2025-01368
• Device Sequence Number: 12794164
• Product Code: NIO
• UDI-Device Identifier: 08717648175985
• UDI-Public: (01)08717648175985(17)251130(10)2120161
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 1012534-40
• Device Catalogue Number: 1012534-40
• Device Lot Number: 2120161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American