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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM
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ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Catalog Number 42055120-080
Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/31/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a popliteal artery with a vessel diameter of 5mm.Pre-dilation was performed with a 6mm balloon at 8 atmospheres during 3 minutes.A 5.5x120mm supera stent was advanced to the lesion.The introducer sheath was 6cm to the proximal end of the stent during deployment.The stent deployed 2cm in the introducer sheath and partially at the lesion.It was decided to partially remove the sheath and the stent implant was able to fully launch at the lesion.It was noted that the stent implant was elongated/stretched.There were no issues with the thumbslide mechanism.The thumb slide was not fully retracted to the start position and both the system and deployment levers locked prior to removal.During removal, resistance was noted with the introducer sheath, and then the distal tip separated in the anterior tibial artery and was not able to be retrieved although multiple attempts with balloons, sheath and a second guidewire were used.Fluoroscopy showed good results with the supera.There was no clinically significant delay.No additional information was provided.
 
Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficult or delayed activation, difficult to remove and material deformation could not be confirmed due to the condition of the returned device.The tip separation was confirmed.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 complaints reported from this lot.In this case, based on the reported information, it is likely that inadequate preparation of the vessel contributed to the difficulties.It should be noted that the stent deployment section of the supera instructions for use (ifu) states: ¿proper vessel / duct sizing, preparation and attention to the pattern of the stent interwoven segments during deployment will help ensure nominal stent length deployment.Expansion to a size smaller than the nominal stent diameter will likely result in an overall stent length longer than the labeled length¿.It may be possible that the vessel diameter was smaller than 5.5 mm, which prevented the stent from fully expanding resulting in elongation of the stent into the introducer sheath.Additionally, the tip detachment likely occurred due to not retracting the thumbslide to the start position and locking the system lock prior to removal causing the tip to catch on the stent and/or introducer sheath during removal.The removal procedure section of the ifu instructs: ¿following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.In this case, it is likely that failing to retract the tip and locking the system lock prior to removal contributed to the tip detachment.The investigation determined that the reported difficulties were likely use related.Based on the reported information, it is likely that inadequate preparation of the vessel contributed to the difficulties.It may be possible that the vessel diameter was smaller than 5.5 mm, which prevented the stent from fully expanding resulting in elongation of the stent into the introducer sheath.Additionally, the tip detachment likely occurred due to not retracting the thumbslide to the start position and locking the system lock prior to removal causing the tip to catch on the stent and/or introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Device code 1601 was removed.
 
Event Description
It was reported that the procedure was to treat a popliteal artery with a vessel diameter of 5mm.Pre-dilation was performed with a 6mm balloon at 8 atmospheres during 3 minutes.A 5.5x120mm supera stent was advanced to the lesion.The introducer sheath was 6cm to the proximal end of the stent during deployment.The stent deployed 2cm in the introducer sheath and partially at the lesion.It was decided to partially remove the sheath and the stent implant was able to fully launch at the lesion.It was noted that the stent implant was elongated/stretched.There were no issues with the thumbslide mechanism.The thumb slide was not fully retracted to the start position and both the system and deployment levers locked prior to removal.During removal, resistance was noted with the introducer sheath, and then the distal tip separated in the anterior tibial artery and was not able to be retrieved although multiple attempts with balloons, sheath and a second guidewire were used.Fluoroscopy showed good results with the supera.There was no clinically significant delay.Per reassessment, the account confirmed that the supera became compressed which is why it elongated.No additional information was provided.
 
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Brand Name
SUPERA SELF-EXPANDING STENT SYSTEM
Type of Device
SELF EXPANDING PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11667546
MDR Text Key245495157
Report Number2024168-2021-03137
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 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Catalogue Number42055120-080
Device Lot Number0072161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2021
Date Manufacturer Received05/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
6F SHEATH SHORT (10CM)
Patient Outcome(s) Required Intervention;
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