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

Catalog Number UNK SUPERA

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat the right popliteal artery.The 5.5x150mm supera self-expanding stent was deployed; however, it was noted that the length was longer and actually a 200mm length.The stent was deployed nominally; however at the 150mm point the stent kept deploying out to 200mm and extended all the way through the old bare metal stent.The delivery system was removed under fluoroscopy.There was no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.It is possible that anatomical conditions and/or deployment technique resulted in the stent to inadvertently deploy longer than expected; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.A cine was received and reviewed by an abbott vascular clinical specialist.In summary: it was reported that a 5.5 x 150m supera self expanding stent was deployed in a right popliteal artery, within an existing bare metal stent.It was reported that the stent deployed as intended, yet reached a length of 200mm.Vessel diameter, vessel prep, and other material/equipment is considered ¿unknown¿ per the report.There are two fluoroscopic still images attached this file, one shows what it appears to be a distal sfa and popliteal artery that has what it appears to be filled with radiopaque contrast.It is unknown if this is a balloon catheter inflated with contrast or if it is a contrast injection within the artery.We are unable to view the proximal end of where the supera stent starts, which is indicated by the account¿s measurement in yellow, vs what they indicate intended length in white.It is unclear where the stent is in this image.The second image shows a zoomed in image of where it appears that two stents (unknown which is the old bare metal and which is the supera stent) where the two stents are overlapping each other as indicated by end radiopaque markers on each.It is unknown where the stents in question originate and end on the media provided.While the media does show specific stents within the distal sfa and popliteal, i cannot determine where the stent begins as the contrast in one image prevent identification of such and the next image shows only a portion of it.While the user does include measurements indicating where the stent is, i cannot confirm on what i cannot see.I cannot come to probable cause for the event with the information provided.Additional information such as sfa and popliteal diameter size to confirm if supera was appropriately sized for both vessels, and additional images of the entire stent without contrast to show the supera stent strut ¿windows¿/cells to confirm if the stent was deployed elongated would be beneficial and may rule out if deployment technique was the probable cause.D4: the udi is unknown due to the part/lot number was not provided.

• Brand Name: SUPERA
• Type of Device: 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: 18914291
• MDR Text Key: 337785584
• Report Number: 2024168-2024-03371
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SUPERA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1