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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 1500400-33
Device Problem Material Separation (1562)
Patient Problem Embolism/Embolus (4438)
Event Date 03/25/2022
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a lesion in the distal right coronary artery (rca). The ostial rca area was stented to treat a catheter induced dissection with no calcification. During placement of a 4. 00x33 mm xience sierra stent, the proximal portion of the stent separated and embolized. The rest of the stent was implanted. A snare was attempted and retrieved the separated portion from the subclavian artery. The patient was hospitalized an extra day and required extra scans. There was no adverse patient sequela. No additional information was provided.
 
Manufacturer Narrative
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 embolism/embolus is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. The investigation was unable to determine a conclusive cause for the reported material separation. Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure. 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 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 Key14167568
MDR Text Key289750771
Report Number2024168-2022-04295
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1500400-33
Device Lot Number1111141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2021
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: 04/21/2022 Patient Sequence Number: 1
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