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

Model Number	1012537-60
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam, activation failure, sheath material separation and stent material deformation were able to be confirmed.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.As there was no damage noted to the device during the inspection prior, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the moderately calcified anatomy and/or inadvertent mishandling resulted in the noted kinked stent sheath resulting in preventing the shaft lumens from moving freely; thus resulting in the reported/noted mechanical jam and the reported/noted activation/deployment failure.Interaction/manipulation of the device as the partially deployed stent was being removed through the sheath resulted in the reported/noted sheath material separation and the reported stent material deformation/noted bent, stretched, broken stent struts.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 moderately calcified lesion in the left iliac artery.A 9x60mm absolute pro self-expanding stent (ses) was advanced through a 6f sheath and over a.035x300cm supra core guidewire to the target lesion, with no noted resistance; however; during deployment the thumbwheel was noted to jam and the stent could only be partially deployed.The ses was removed through the sheath and a new non-abbott stent was deployed to complete the procedure.There were no adverse patient effects nor clinical delay.Subsequent to the initially reported event, the device was received and the returned device analysis revealed that the stent sheath was separated 2 cm from the distal end of the tip, and the distal end of the stent implant was bent, stretched, and had broken struts.Follow-up with the account confirmed that all noted damages found in the device analysis occurred during the procedure when the portion of the stent that was deployed was re-sheathed and pulled through the 6f sheath for removal.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: 21375992
• Report Number: 2024168-2025-01642
• Device Sequence Number: 3826066
• Product Code: NIO
• UDI-Device Identifier: 08717648176234
• UDI-Public: (01)08717648176234(17)270630(10)4072362
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/13/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012537-60
• Device Catalogue Number: 1012537-60
• Device Lot Number: 4072362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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 X 300CM SUPRA CORE; SHEATH: 55CM 6F
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American