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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM
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AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM Back to Search Results
Catalog Number S50120120-P6
Device Problems Difficult to Advance (2920); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2018
Event Type  Injury  
Manufacturer Narrative
Internal file number - (b)(4).Catalog number updated from s50120100-coo to s50120120-p6.The device was not returned for analysis.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 incidents.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Correction: the physician did not feel any resistance upon removal of the delivery system and confirmed the stent was fully deployed so it must have migrated.No additional information was provided.
 
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Brand Name
SUPERA SELF-EXPANDING STENT SYSTEM
Type of Device
SELF EXPANDING STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key8248706
MDR Text Key309483697
Report Number2024168-2019-00352
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,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue NumberS50120120-P6
Device Lot Number8072661
Was Device Available for Evaluation? No
Date Manufacturer Received02/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight68
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