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

Model Number	S-65-150-120-P6
Medical Device Problem Codes	Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
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 performed was to treat a mildly calcified, mildly tortuous superficial femoral artery that is 90% stenosed.The 6.5x150mm supera peripheral stent system was partially deployed to about 10cm as it was noted that the thumbslide became difficult to use and could no longer move.The supera was removed under fluoroscopy and a new 6.5x150mm supera was used to complete the procedure.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported mechanical jam and the reported activation failure were unable to be confirmed.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.Potential causes for activation failure and resistance with the thumbwheel include, but are not limited to, manufacturing, anatomical conditions; deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens/ratchet), or inadequate pre-dilatation of the stricture.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigation have been established for potential causes.The investigation determined the reported 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 mildly calcified, mildly tortuous and 90% stenosed anatomy such that the ratchet was unable to properly/fully engage the stent resulting in difficulty advancing the thumbslide/ mechanical jam and 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.

• 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: 20799827
• Report Number: 2024168-2024-14018
• Device Sequence Number: 20580468
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: (01)08717648226328(17)260131(10)4022761
• 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): 01/16/2025

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: 01/31/2026
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 4022761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Patient Sex: Unknown