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

Model Number	1012534-100
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (elhr) 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 likely that the distal shaft was bent in the heavily calcified and mildly tortuous anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam and the reported/noted activation/deployment.Interaction and/or manipulation of the device resulted in the noted device damages (twisted distal sheath, multiple inner member kinks, multiple retractable sheath bends/kinks, hypotube kink) likely contributing to the reported difficulties.As reported, the handle of the sess was opened up (resulting in the noted bent handle peg) and the stent was deployed in the target lesion.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 to treat a heavily calcified and mildly tortuous unspecified circulatory vessel.The 6x100mm abs pro vascular self expanding stent system (sess) was advanced to the target lesion and the stent was attempted to be deployed; however, the thumbwheel would not spin and the stent could not be deployed.The handle of the sess was opened and the stent was then able to be deployed in the target lesion.There was adverse patient sequela and no clinically significant delay reported in the procedure.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: 20248230
• Report Number: 2024168-2024-11029
• Device Sequence Number: 7366171
• Product Code: NIO
• UDI-Device Identifier: 08717648176012
• UDI-Public: (01)08717648176012(17)270531(10)4060461
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 09/18/2024

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 Model Number: 1012534-100
• Device Catalogue Number: 1012534-100
• Device Lot Number: 4060461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 52 KG