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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM
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ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 42045060-080
Device Problems Entrapment of Device (1212); Difficult or Delayed Activation (2577); Device Damaged by Another Device (2915); Mechanical Jam (2983); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984); Thrombosis (2100)
Event Date 11/11/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported at the 20th union conference of the swiss societies for vascular diseases (usgg luzern) a case for a mildly tortuous, mildly calcified popliteal artery with a 4.5x60mm supera self-expanding stent.Atherectomy was not performed but the vessel was prepped with a 4x40mm non-abbott balloon at 12-14 atmospheres.The physician initiated deployment and opened and closed the deployment lock several times and moved the thumbslide multiple times back and forth.There was some resistance (more than usual) felt during handling and placement when sliding the thumbslide.It was thought that the stent had deployed.When removing the delivery system, the stent deployed fully inside a previously implanted supera stent from a 2010 procedure.Then a drug-eluting balloon was used in the popliteal and an absolute pro in the proximal superficial femoral artery to successfully complete the procedure.Ten days later, the supera stent that had been recently deployed was noted as occluded.The physician noted there was no clinically significant delay or adverse patient effects at the time of the procedure.No additional information was provided.
 
Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficulties were unable to be confirmed, as the stent was already fully deployed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.The reported patient effect of thrombosis is listed in the supera instructions for use as a known potential patient effect associated with the use of the device.An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images that were provided.The review noted that the images provided show a supera stent and delivery system at the end of the deployment cycle.It appears that the proximal end of the supera is still inside the tip of the delivery catheter.Subsequent image shows the newly deployed supera in a more proximal location within a previously deployed supera.In this case, based on the reported information and analysis of the returned device, a definitive cause for the difficulties could not be determined.The investigation was unable to determine a cause for the reported difficulties.The entrapment of device and damage caused by another device was the result of pulling the partially deployed supera stent through the previously deployed supera stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3, d6: date of event/implant changed from (b)(6) 2019 to (b)(6) 2019.Patient code 1984 removed device codes 2577, 4012 were removed.
 
Event Description
It was reported at the 20th union conference of the swiss societies for vascular diseases (usgg luzern) a case for a mildly tortuous, mildly calcified popliteal artery with a 4.5x60mm supera self-expanding stent.Atherectomy was not performed but the vessel was prepped with a 4x40mm non-abbott balloon at 12-14 atmospheres.The physician initiated deployment and opened and closed the deployment lock several times and moved the thumbslide multiple times back and forth.There was some resistance (more than usual) felt during handling and placement when sliding the thumbslide.It was thought that the stent had deployed.When removing the delivery system, the stent deployed fully inside a previously implanted supera stent from a 2010 procedure.Then a drug-eluting balloon was used in the popliteal and an absolute pro in the proximal superficial femoral artery to successfully complete the procedure.Ten days later, the supera stent that had been recently deployed was noted as occluded.The physician noted there was no clinically significant delay or adverse patient effects at the time of the procedure.No additional information was provided.Additional information received states that the supera stent was being removed as it failed to deploy.During removal it got stuck on the previously deployed 2010 supera stent and inadvertently deployed at an unintended site (within the 2010 supera stent).Therefore the supera stent was embedded within the 2010 supera stent with a drug-eluting balloon.The patient was re-hospitalized 10 days post stent implantation for thrombosis and was treated with a drug-eluting balloon.No additional information was provided.
 
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Brand Name
SUPERA PERIPHERAL STENT SYSTEM
Type of Device
SELF EXPANDING PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9498496
MDR Text Key174911824
Report Number2024168-2019-14794
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
PMA/PMN Number
P120020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue Number42045060-080
Device Lot Number8101861
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2019
Date Manufacturer Received02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SUPERA
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
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