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

Catalog Number UNK SUPERA

Device Problems Difficult to Remove (1528); Stretched (1601); Difficult or Delayed Activation (2577); Defective Device (2588); Difficult to Advance (2920)

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

Event Date 08/11/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified superficial femoral artery and was pre-dilatated with an unspecified balloon.The supera was advanced and during deployment once almost complete the stent crimped up.An unspecified balloon was attempted to advanced; however, could not get through the supera stent.Cut down was performed to remove the stent was explanted and a new supera was used to re-stent.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4: the udi is unknown due to the part/lot number was not provided.

Event Description

Subsequent to the previously filed report, the following information was provided: it was noted that a 6x120mm supera did not crimp up during deployment.The stent was fully deployed and elongated.Wire access was lost an attempt to rewire was performed; however, the wire became stuck between the stent struts.Unspecified balloon was also attempted to advance, but also got stuck with the stent.Therefore, surgical intervention was required.User facility medwatch report received that states "procedure: open exploration of right distal sfa-p1 with removal of supera stent and coronary balloon percutaneous balloon angioplasty and stent reconstruction of right popliteal and distal sfa percutaneous balloon angioplasty and stenting of prox p2+p1 + distal sfa with 6 mm balloon removal of existing left 6f sheath - closure with celt device md attempted recanalization of long segment right sfa-pop occlusion.During this process, md successfully achieved traversal of occlusion of the common peroneal artery and established continuous flow to the posterior tibial artery.But, with use of the supera stent system in the popliteal and distal sfa position, md's balloon became entrapped in the supera stent.This could not be resolved.Hence, patient comes now to the operating room for removal of the intravascular foreign bodies, and completion of the recanalization procedure if possible.".

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.As there was no reported damage noted to the device during the inspection prior to use, it is possible that interaction with the extremely calcified anatomy resulted in the reported difficult or delayed activation; however this cannot be confirmed.Additionally, it is possible that interaction with the extremely calcified anatomy and/or interaction with the deployed stent as the guidewire was attempted to be advanced resulted in the reported difficult to advance, the reported difficult to remove and ultimately resulted in the reported stretched stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure a reportedly a cut down was performed to remove the stent and a new supera was used to re-stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.B5 - describe event or problem: updated.D9, h3 - device returning updated from yes to no.H6 - code 2588 was removed and code 1601, 1528 were added.

• 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: 17645895
• MDR Text Key: 322218632
• Report Number: 2024168-2023-09443
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• 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: 10/23/2023
• 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
• Patient Outcome(s): Required Intervention