MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-60-040-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
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, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that the distal sheath of the delivery system was entrapped or bent in the 90% anatomy such that the ratchet was unable to properly/fully engage the stent resulting in reported activation/deployment failure.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 90% stenosed lesion in the superficial femoral artery (sfa) with a vessel diameter of 6.5mm.After the lesion was prepared with a 7mm dilatation balloon to 10 atmospheres, a 6x40mm supera self-expanding stent (ses) was attempted to be deployed at the lesion; however, it was noted that the stent only partially deployed.The ses was removed and another same sized supera was used to complete the procedure.There were no reported adverse patient sequela nor clinically significant delay.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a 90% stenosed lesion in the superficial femoral artery (sfa) with a vessel diameter of 6.5mm.After the lesion was prepared with a 7mm dilatation balloon to 10 atmospheres, a 6x40mm supera self-expanding stent (ses) was attempted to be deployed at the lesion; however, it was noted that the stent only partially deployed.The ses was removed and another same sized supera was used to complete the procedure.There were no reported adverse patient sequela nor clinically significant delay.Subsequent to the initially filed report, analysis of the returned device revealed that the stent implant was deployed and the tip jacket and inner member were separated at the distal end of the ratchet stem.Follow-up with the site was performed and they responded stating they were not aware of the separation.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that the distal sheath of the delivery system was entrapped or bent in the 90% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in reported activation/deployment failure.Manipulation of the device resulted in the noted device damages (separated tip/tip jacket/inner) likely contributing to the reported difficulties.Reportedly, the stent was deployed outside the anatomy and discarded.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.B5: describe event or problem updated d9: device available for evaluation updated from no to yes h6: component code 829 added.H6: type of investigation code 4115 removed; 10 added.H6: investigation conclusions code 50 removed; 4311 added.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: 20723882
• Report Number: 2024168-2024-13648
• Device Sequence Number: 3782593
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: (01)08717648211799(17)251031(10)3112061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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 Expiration Date: 10/31/2025
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 3112061
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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
• Patient Sex: Unknown