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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 42050100-120
Device Problems Break (1069); Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during prep, an unspecified command 18 guide wire could not be inserted into a 5x100mm supera self-expanding stent system (sess).The tip of the sess was noted to be displaced [broken] but not separated.The sess was not used and there was no patient involvement.The guide wire was used with an unspecified supera to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported difficulty to insert was not tested based on device condition and guidewire not returned.The reported break was unable to be confirmed.There was additional damage noted to the inner member as it was stretched and wrinkled.A noted kink was found on the shaft likely cause by circumstances.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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the reported loose tip (nose cone) was inadvertently handled during preparation and affected the integrity of the inner member and as such the command 18 guide wire was not able to properly be loaded during insertion causing difficulty to insert; however, this could not be confirmed.The noted kink to the shaft is likely caused by case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
 
Manufacturer Narrative
The device was returned for analysis.The reported difficulty to insert was not tested based on device condition and guidewire not returned.The reported break was unable to be confirmed.There was additional damage noted to the inner member as it was stretched and wrinkled.A noted kink was found on the shaft likely cause by circumstances.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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the reported loose tip (nose cone) was inadvertently handled during preparation and affected the integrity of the inner member and as such the command 18 guide wire was not able to properly be loaded during insertion causing difficulty to insert; however, this could not be confirmed.The noted kink to the shaft is likely caused by case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key11734113
MDR Text Key247581005
Report Number2024168-2021-03566
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,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2022
Device Catalogue Number42050100-120
Device Lot Number0112361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2021
Date Manufacturer Received06/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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