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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 1500300-15
Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  Malfunction  
Manufacturer Narrative

The device will not be returning. The investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was performed to treat a lesion in the left anterior descending coronary artery. A 3x15mm xience sierra stent was implanted without difficulty. An unspecified guide wire was advanced but failed to cross the xience sierra stent, so a non-abbott guide wire was advanced which interacted with the previous guide wire. The stent then became caught in the guide wires and was explanted when the guide wires were retrieved using a lasso through an unspecified introducer sheath. An unspecified stent was then used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in 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 Key10518337
MDR Text Key217674991
Report Number2024168-2020-07587
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)Y
Reporter Country CodeFR
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,Followup,Followup
Report Date 10/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1500300-15
Device LOT Number0030441
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 09/10/2020 Patient Sequence Number: 1
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