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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1500350-15
Device Problems Product Quality Problem (1506); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2022
Event Type  malfunction  
Manufacturer Narrative
The device was returned for analysis. The reported unknown damage was confirmed with the noted inner/outer member separation. 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 similar incidents from this lot. The investigation was unable to determine a conclusive cause for the reported unknown damage; however, a shaft separation and shaft damage was noted during return evaluation of the device. Potential causes for material separation include, but are not limited to, damage during manufacturing, interaction with accessory devices, and/or inadvertent mishandling during unpackaging. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that during preparation and before use deterioration of the device was noted. The device was not used, there was no patient involvement and no reported clinically significant delay in the procedure. Device analysis revealed the inner and outer member of the stent delivery system were separated distal to the guide wire exit notch. No additional information was provided.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key14174372
MDR Text Key289906237
Report Number2024168-2022-04323
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1500350-15
Device Lot Number0070241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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