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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550350-15
Device Problems Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation
Event Date 12/20/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 performed to treat a lesion in the right coronary artery (rca). A 3. 5x15mm xience sierra stent delivery system (sds) was advanced; however, not deployed. The sds was removed from the patient and re-inserted over the wire. At this point, flaring was noted before the stent was inserted back into the patient anatomy. At some point during this process, a bend in the artery was noted and the undeployed stent dislodged and remained in the proximal rca. The patient was sent to another hospital for another cardiac catheter procedure. The stent was crushed in place with another stent and balloon. The patient is doing fine. No additional information was provided.

 
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Brand NameXIENCE SIERRA
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 Key9630016
Report Number2024168-2020-00891
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1550350-15
Device Catalogue Number1550350-15
Device LOT Number9092341
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/30/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/24/2020 Patient Sequence Number: 1
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