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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1550350-12
Device Problems Unintended System Motion (1430); Patient-Device Incompatibility (2682)
Patient Problem Prolapse (2475)
Event Date 08/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The stent remains in the vessel; the customer reported the delivery system was discarded. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that during a procedure of the proximal circumflex artery, after pre-dilatation and during stent deployment, the 3. 5 x 12 mm xience sierra stent watermelon seeded/moved proximal, partially into the left main (lm) artery, but was implanted in the proximal cx to lm. Plaque shift was noted in the ostial circumflex and the stent was under expanded due to the plaque shift. The ostial cx stent was pinched and the vessel 60 % occluded. Additional dilatation was attempted, but the balloon dilatation catheter could not cross to the stented area. The procedure was terminated with timi3 flow in all vessels. There was no reported adverse patient sequela or a clinically significant delay in procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no similar incidents from this lot. The reported patient effect of prolapse is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effect of coronary stenting procedures. A cine was received and reviewed by an abbott vascular clinical specialist which concluded the stent migrated proximally, requiring additional intervention to resolve. It is possible that interaction with the anatomy/plaque as the device was inflated resulted in the reported difficulty to deploy (movement, wall opposition); however, this cannot be confirmed. Additionally, the reported difficulties possibly resulted in the reported patient effects; however, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7814911
MDR Text Key241263902
Report Number2024168-2018-06590
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2019
Device Catalogue Number1550350-12
Device Lot Number8051842
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/24/2018 Patient Sequence Number: 1
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