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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 1550225-38
Device Problems Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). The stent remains in the patient. 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 heavily tortuous and heavily calcified lesion in the second diagonal coronary artery. A 2. 75x38mm xience sierra stent delivery system (sds) failed to cross due to the anatomy. The sds was removed without issues. An attempt to advance a 2. 25x38mm xience sierra sds was made, however, this too failed to cross due to the anatomy. The patient was re-wired and a guideliner was placed. The same 2. 25x38mm xience sierra sds was re-attempted and failed to cross again. During removal of the sds, the stent dislodged and all was removed as a single unit. At the time it was thought that the stent would be in the guideliner; however, this was not the case as the dislodged stent remained in the left anterior descending (lad) coronary artery. The dislodged stent was crushed against the vessel wall via balloon dilatation. The lad then developed thrombus and an attempt to re-wire was made for additional treatment. During re-wiring with an unspecified guide wire, the wire was entering the subintimal lad when a dissection occurred. An impella device was implanted and the patient was sent for a coronary artery bypass graft (cabg). There was no additional adverse patient sequela reported at this time. 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 Key9511682
Report Number2024168-2019-14931
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number1550225-38
Device Catalogue Number1550225-38
Device LOT Number9042641
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 Received01/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/03/2019
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: 12/23/2019 Patient Sequence Number: 1
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