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

Model Number	S-50-080-120-P6
Medical Device Problem Codes	Stretched (1601); Difficult or Delayed Activation (2577); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and tortuous lesion in the superficial femoral artery (sfa), with a vessel diameter of 5mm.After pre-dilatation to 8atm, with a 5mm unknown balloon catheter, a 5x80mm supera peripheral self expanding stent (ses) was advanced through a 6f sheath and was attempted to be deployed at the lesion; however, the stent could only be four-fifths of the way deployed after several attempts to push the thumb slider.The physician decided to open the handle in order to release the latch but was still unable to deploy the stent.The ses was forcibly pulled out, causing the stent to stretch and deform inside the anatomy, with part of the stent at the target lesion and part remaining in healthy tissue.A non-abbott dilatation balloon was used to treat the stretched and deformed stent, and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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 difficult or delayed activation and the reported mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device.The reported stretched stent was unable to be confirmed as the stent was not returned.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 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 the distal sheath of the delivery system was entrapped or bent in the moderately calcified and torturous anatomy such that the ratchet was unable to properly/fully engage the stent resulting in the reported mechanical jam and the reported difficult or delayed activation.Manipulation of the compromised device resulted in the reported stretched stent.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.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified and tortuous lesion in the superficial femoral artery (sfa), with a vessel diameter of 5mm.After pre-dilatation to 8atm, with a 5mm unknown balloon catheter, a 5x80mm supera peripheral self expanding stent (ses) was advanced through a 6f sheath and was attempted to be deployed at the lesion; however, the stent could only be four-fifths of the way deployed after several attempts to push the thumb slider.The physician decided to open the handle in order to release the latch, but was still unable to deploy the stent.The ses was forcibly pulled out, causing the stent to stretch and deform inside the anatomy, with part of the stent at the target lesion and part remaining in healthy tissue.A non-abbott dilatation balloon was used to treat the stretched and deformed stent, and the procedure was completed.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, additional information was received.The handle was not opened in order to deploy the stent.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: 20619749
• Report Number: 2024168-2024-12974
• Device Sequence Number: 8898373
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: (01)08717648211751(17)250930(10)3102761
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/02/2025

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: 09/30/2025
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 3102761
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• 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: SHEATH: 6F,40CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown