MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-65-040-120-P6
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the left superior femoral artery (sfa) with heavy calcification and mild tortuosity.Using a crossover technique to avoid resistance and after pre-dilation with a non-abbott balloon dilatation catheter (bdc), a 6.5x40mm supera peripheral self expanding stent system (sess) was advanced to the target lesion.However, during deployment, resistance was felt advancing the thumbslide.The stent partially deployed and the thumbslide became stuck.A puncher needle was used to keep the stent at the target lesion and the delivery system was pulled slightly to complete the stent deployment.Although deployment was difficult, the stent was able to be deployed at the intended location.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during stent deployment interaction with the heavily calcified and mildly tortuous anatomy resulted in the ratchet being unable to properly engage/fully deploy the stent; thus resulting in reported physical resistance and the reported difficult activation.The treatment appears to be related to the operational context of the procedure as a puncture needle was used to keep the stent at the target lesion and the delivery system was pulled slightly to complete the stent deployment.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 13334455
• Report Number: 2024168-2022-00773
• Device Sequence Number: 14663315
• Product Code: NIP
• UDI-Device Identifier: 08717648226229
• UDI-Public: 08717648226229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 03/31/2023
• Device Model Number: S-65-040-120-P6
• Device Catalogue Number: S-65-040-120-P6
• Device Lot Number: 1040261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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