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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 1500400-38
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/18/2020
Event Type  Malfunction  
Manufacturer Narrative

The device is expected to be returned for investigation. 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 to treat st elevation mi (st-segment elevation myocardial infarction) due to a blocked, mildly calcified, tortuous right coronary artery (rca). During advancement of the 4x38mm xience sierra drug eluting stent system (des), resistance was noted through the guide catheter so a guideliner was inserted, but the device became stuck in the guideliner. Both the stent system and guideliner were removed as a single unit. There was no adverse patient effect or a clinically significant delay in the procedure. A non-abbott stent was implanted to successfully complete the procedure. 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 Key10525141
MDR Text Key207037489
Report Number2024168-2020-07619
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)Y
Reporter Country CodeUK
PMA/PMN NumberP110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1500400-38
Device LOT Number9080241
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Is this a Reprocessed and Reused Single-Use Device? No

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