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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 42045120-120
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problems Death (1802); Ischemia (1942)
Event Date 05/14/2020
Event Type  Death  
Manufacturer Narrative
Date of event has been estimated.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 performed to treat a stenosed popliteal artery.The 4.5x120 supera self-expanding stent delivery system was advanced to the target lesion using a 6f non-abbott introducer and an ht command 18 guide wire.During the release of the stent, the tip separated.It was then noted that there was very little flow.A non-abbott 4mm balloon failed to cross.A different non-abbott balloon then crossed the lesion, but it was not able to dilate the area.Finally, the physician decided to perform a bypass surgery where they retrieved the tip and the stent.After the procedure (exact date not provided), the patient died.No additional information was provided.
 
Event Description
It was reported that the procedure was performed to treat a stenosed popliteal artery.The 4.5x120 supera self-expanding stent delivery system was advanced to the target lesion using a 6f non-abbott introducer and an ht command 18 guide wire.During the release of the stent, the tip separated.It was then noted that there was very little flow.A non-abbott 4mm balloon failed to cross.A different non-abbott balloon then crossed the lesion, but it was not able to dilate the area.Finally, the physician decided to perform a bypass surgery where they retrieved the tip and the stent.After the procedure (exact date not provided), the patient died.Correction to b5: the following case details were inadvertently left out of the case details filed in the iniital report: the lesion was pre-dilated with a non-abbott balloon (4mm) to the break pressure.After using the balloon the lesion was uniform, and the physician did not want to dilate more and they tried to place a supera stent (4.5x120).Additional information received subsequent to filing the initial report: the patient died the day after the procedure on(b)(6)2020.In the physicians opinion, the supera did cause or contribute to the death.No additional information was provided.
 
Manufacturer Narrative
Device code 2017 - failure to follow steps / instructions visual analysis was performed on the returned unit.The reported tip detachment was confirmed during analysis.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.It should be noted that the supera instruction for use states: prepare the vessel / duct utilizing standard angioplasty technique using a balloon size greater than the stent outer diameter.Refer to the balloon¿s instructions for use.Per the pre-dilation sizing table in the ifu, a 4.5 mm stent requires a recommended minimum inflated balloon diameter of greater that 4.5 mm.In this case, it was reported that the lesion was dilated with a non-abbott balloon (4mm) to the break pressure.After using the balloon, the lesion was uniform, and the physician did not want to dilate more, and they tried to place the supera stent (4.5x120).It could not be determined if inadequate vessel preparation contributed to the difficulties.The investigation was unable to determine a cause for the reported tip separation and subsequent patient effects.The reported patient effects of hemorrhage, ischemia and death are listed in the supera instructions for use as known potential adverse effects of peripheral percutaneous intervention.In this case, a conclusive cause for the patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: case details h6: device code 2017 added.
 
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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 Key10109897
MDR Text Key193357941
Report Number2024168-2020-04662
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 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2021
Device Catalogue Number42045120-120
Device Lot Number0010661
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FLEXOR INTRODUCER 6FX55CM; HT COMMAND 18 GUIDEWIRE 300CM; FLEXOR INTRODUCER 6FX55CM; HT COMMAND 18 GUIDEWIRE 300CM
Patient Outcome(s) Death;
Patient Age87 YR
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