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

Model Number	S-55-060-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (lhr) 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.Reportedly, the delivery system was not removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions for use (ifu) states: under fluoroscopy, continuously and slowly retract and advance the thumb slide multiple times.Each full advancement of the thumb slide will only deploy a short section of the stent.Repeat until the thumb slide advancement no longer deploys the stent.While maintaining increased magnification, rotate the deployment lock to the unlocked position.Under fluoroscopy, slowly advance the thumb slide to the distal most position on the handle.Confirm under fluoroscopy that the entire supera stent has emerged from the outer sheath and is released.Section 9.6 removal procedure further 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.Under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and deviation of the ifu as it is likely that during deployment the stent was inadvertently not fully/entirely deployed from the device; thus during device removal (without the use of fluoroscopy) the stent was inadvertently removed with the device resulting in the 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.H6: medical device problem code 2017 clarifier- incorrect removal.
Event or Problem Description
It was reported that the procedure was to treat a right sfa and popliteal artery.The 5.5x60mm supera self expanding stent system (sess) was used with a 6fr sheath.The stent was deployed and the sess was retracted.Once the sess was removed, it was noted that the stent came back with the sheath (remained in the sheath); therefore, a non-abbott stent was used to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• 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: 20305201
• Report Number: 2024168-2024-11316
• Device Sequence Number: 7726183
• Product Code: NIP
• UDI-Device Identifier: 08717648226083
• UDI-Public: (01)08717648226083(17)260331(10)4040361
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/25/2024

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: 03/31/2026
• Device Model Number: S-55-060-120-P6
• Device Catalogue Number: S-55-060-120-P6
• Device Lot Number: 4040361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .014 COMMAND GUIDE WIRE; 6 FR SHEATH
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG