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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
Model Number 1550225-15
Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event. Based on review of the similar incidents, there is no indication of a lot specific issue. The investigation determined the reported failure to advance, difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure. Based on the reported information, it is likely that the anatomical condition caused resistance during advancement which then caused the stent delivery system to become caught in the previously implanted stent. Manipulation against resistance likely resulted in the reported stent dislodgment. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a concentric, heavily calcified, heavily tortuous, 90% stenosed, de novo proximal left circumflex (plcx). After lesion pre-dilatation, a 2. 25x15mm xience sierra drug eluting stent (des) was advanced but due to the anatomy, became stuck with a the previously implanted stent in the circumflex and dislodged. A snare was attempted to grab it and pull it out but failed. A non-abbott device was used to push the dislodged sierra stent against the previously implanted stent and another sierra stent was advanced and implanted to embed the dislodged stent into the previously implanted stent. Post- dilatation was performed. There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy. The lesion was again pre-dilated and a non-abbott stent was implanted to 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 Key10550402
MDR Text Key207492108
Report Number2024168-2020-07820
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/04/2021
Device Model Number1550225-15
Device Catalogue Number1550225-15
Device Lot Number811284A
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 Received08/28/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
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