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

Model Number	1012535-80
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
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 left external iliac.A 7.0x80mm absolute pro self expanding stent system (ses) was advanced to the lesion through the common femoral artery and deployed at the target lesion; however during deployment the thumbwheel was noted to stop with part of the stent still inside the delivery catheter.The device was attempted to be removed however resistance was felt and the stent was noted to be stretched, with 50% in the target lesion and 50% stretched and lodged in the right common femoral artery.The stent separated at the stretched portion in the tissue track.A surgical cut down was performed at the right common femoral artery and the separated stent was removed.The part of the stent that was successfully deployed in the target lesion was post dilated and another stent was deployed to cover the remaining part of the lesion to complete the procedure.There was a clinically significant delay.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 returned for analysis.The reported mechanical jam was able to be confirmed.The reported activation failure, stretched stent and the reported stent material separation were unable to be replicated in a testing environment due to the condition of the returned device (stent deployed and not returned).The reported difficult to remove unable to be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.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 moderately calcified anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported/noted mechanical jam and the reported activation/deployment failure.Manipulation of the device resulted in the noted device damages (multiple kinked stent sheath, multiple jacket bends) likely contributing to the reported difficulties, resulting in the reported difficult to remove and ultimately resulting in the reported stretched and separated stent.The treatment appears to be related to the operational context of the procedure as reportedly a surgical cut down was performed at the right common femoral artery and the separated stent was removed.The part of the stent that was successfully deployed in the target lesion was post dilated and another stent was deployed to cover the remaining part of the lesion to complete the procedure.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: 20334104
• Report Number: 2024168-2024-11479
• Device Sequence Number: 20834089
• Product Code: NIO
• UDI-Device Identifier: 08717648176081
• UDI-Public: (01)08717648176081(17)270331(10)4041861
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/18/2024

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: 1012535-80
• Device Catalogue Number: 1012535-80
• Device Lot Number: 4041861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG