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

Model Number	S-70-100-120-P6
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat the superficial femoral artery.The vessel diameter was 7.0mm and was predilated with a 7.0mm balloon dilatation catheter.A 6fr x 45cm sheath was used during the procedure.The 7.0x100mm supera stent was deployed at the target vessel, but the supera tip got caught on the stent and sheared off.The thumb slide was not fully retracted to the start position and both the system with deployment levers locked prior to removal.The separated tip was snared.There was no damage to the implanted supera stent in the target vessel.There was no adverse patient effect and no clinically significant delay during the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6 - medical device problem code 2017 clarifier: failure to follow steps / instructions.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 material separation was able to be confirmed.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 query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.Reportedly, the thumb slide was not fully retracted to the start position and both the system and deployment levers locked prior to removal.It should be noted that the supera peripheral stent system instructions for use ifu, states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.As the reported deviation of the instructions for use appears to have caused/contributed to the reported difficulties as in-service letter to the physician will be required.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that against the instructions for use, prior to withdrawal the device was removed without the thumb slide fully retracted to the start position and locking both the system lock and deployment lock; thus resulting in the tip of the device inadvertently getting caught with the deployed stent and ultimately resulting in the reported tip material separation/noted tip jacket and the inner member separations.Manipulation of the device likely resulted in the noted sheath kink.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: 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: 19643597
• Report Number: 2024168-2024-07830
• Device Sequence Number: 12418253
• Product Code: NIP
• UDI-Device Identifier: 08717648350627
• UDI-Public: (01)08717648350627(17)250430(10)3050861
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• 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): 08/05/2024

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 Expiration Date: 04/30/2025
• Device Model Number: S-70-100-120-P6
• Device Catalogue Number: S-70-100-120-P6
• Device Lot Number: 3050861
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 59 KG