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

Model Number	S-45-060-120-P6
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the right popliteal artery with moderate calcification, soft plaque, 50-60% stenosis and no tortuosity via pedal access.The area had multiple prior interventions.The 4.5x60 mm supera self expanding stent system (sess) had issues going through the 6fr sheath.After 3 failed attempts to advance the sess to the desired location, the device was removed and the nose cone caught the tip of the sheath during removal.The stent began to deploy inside the sheath but was able to be removed entirely before full deployment occurred.The pedal access caused crimping of the stent.The sheath was exchanged and a new supera sess were used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed mdr report, returned device analysis identified that the tip was separated and not returned.Follow up found that the account was aware of the separation, as it occurred during removal of the supera stent delivery system when the nose cone caught on the sheath.The separated tip was removed when both devices were removed together.The separated tip was discarded.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported premature activation and the reported material separation were able to be confirmed.The reported material deformation was unable to be confirmed.The reported difficult to advance and difficult to remove and were unable to be replicated in a testing environment as they were based on operational circumstances.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 similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 6fr sheath resulted in the reported difficult to advance.During removal, the nose cone inadvertently got caught on the tip of the 6fr sheath resulting in the reported difficult to remove.Manipulation of the compromised device resulted in the device sheath to slightly retract thus resulting in the stent to inadvertently prematurely deploy and ultimately resulted in the reported material separation /noted tip jacket and inner member separations and the noted separated/torn distal marker.As reported, the tip was removed when both devices were removed together and was discarded.The reported material deformation was unable to be confirmed.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.Corrections: d1 ¿ brand name: updated.D2a ¿ common device name: updated.D3 ¿ name, address 1, city, postal code: updated.

• 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: 19374792
• Report Number: 2024168-2024-06218
• Device Sequence Number: 18024564
• Product Code: NIP
• UDI-Device Identifier: 08717648225949
• UDI-Public: (01)08717648225949(17)250430(10)3053161
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 04/30/2025
• Device Model Number: S-45-060-120-P6
• Device Catalogue Number: S-45-060-120-P6
• Device Lot Number: 3053161
• 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: 05/03/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED 6FR SHEATH
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Race: White