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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 42045030-120
Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2024
Event Type  Injury  
Manufacturer Narrative
D4: the udi is unknown due to the part/lot number was not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional supera device referenced in b5 is filed under separate medwatch report number.
 
Event Description
It was reported two supera stents were implanted however the tips of both stents were broken off.No additional information was provided.
 
Manufacturer Narrative
B1: adverse event selected.B2: added required intervention.D4: updated part and lot numbers from unknown to 42045030-120 and 2031861.D4: updated expiration date.H1: updated type of event from malfunction to serious injury.H4: added device manufacture date.H6: codes 4582, 2199, 1069 removed, codes 2687, 4641, 1562, 2920, 1528, and 2017 added device code 2017: failure to follow steps.
 
Event Description
Subsequent to the initially filed reports, additional information was provided: it was reported the procedure was to treat a highly tortuous and calcified arteria mesenterica inferior.The lesion was pre-dilated with a 3mm balloon.The 4.50x30mm supera self expanding stent system (ses) was advanced with resistance noted with the introducer sheath.The stent was deployed successfully.During removal, the thumbslide was not fully retracted to the start position.Resistance was met with the anatomy and the tip of the ses detached.A second supera of the same size was advanced however could not pass through the first implanted stent.During removal resistance was met and the tip separated and the stent came out of the sheath.The stent was able to be removed.Attempts were made to snare both separated tips but were unsuccessful and the tips remain in the patient anatomy.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance- introducer sheath was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to advance-crossability and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent deviation of the instructions for use as it is likely that during advancement interaction with introducer sheath resulted in the reported difficult to advance.After successfully deploying the stent, during device removal interaction with the highly tortuous and calcified anatomy in conjunction with not fully retracting the thumbslide to the start position per the instructions for use resulted in the reported difficult to remove and ultimately resulted in the reported tip material separation/noted tip jacket and inner member separations.As reported, attempts were made to snare the separated tip but were unsuccessful and the tip remains in the patient anatomy.Reportedly, during removal the thumbslide was not fully retracted to the start position.It should be noted that the supera peripheral stent system instructions for use (ifu) states: 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.As the deviation of the instructions for use appears to have caused/contributed to the reported difficulties the deviation will be addressed in the account requested letter.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the initially filed reports, additional information was provided: it was reported the procedure was to treat a highly tortuous and calcified arteria mesenterica inferior.The lesion was pre-dilated with a 3mm balloon.The 4.50x30mm supera self expanding stent system (ses) was advanced with resistance noted with the introducer sheath.The stent was deployed successfully.During removal, the thumbslide was not fully retracted to the start position.Resistance was met with the anatomy and the tip of the ses detached.A second supera of the same size was advanced however could not pass through the first implanted stent.During removal resistance was met and the tip separated and the stent came out of the sheath.The stent was able to be removed.Attempts were made to snare both separated tips but were unsuccessful and the tips remain in the patient anatomy.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
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 Key18825280
MDR Text Key336788061
Report Number2024168-2024-02676
Device Sequence Number1
Product Code NIP
UDI-Device Identifier08717648224850
UDI-Public(01)08717648224850(17)240229(10)2031861
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P120020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/03/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Catalogue Number42045030-120
Device Lot Number2031861
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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