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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 1550350-28
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Embolism (1829); Foreign Body In Patient (2687)
Event Date 08/25/2020
Event Type  Injury  
Manufacturer Narrative
A visual inspection was performed on the returned device. The reported stent dislodgement was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar incidents from this lot. The reported patient effect of embolism is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures. The investigation was unable to determine a conclusive cause for the reported stent dislodgement. A conclusive cause for the reported patient effects, 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 the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a lesion in an unspecified vessel. Atherectomy was performed using a non-abbott device. The 3. 5 x 28 mm xience sierra stent delivery system was then advanced. Resistance was noted at the target site and force was applied. The xience sierra stent dislodged and embolized to the left iliac artery. A balloon dilatation catheter was advanced to the dislodged stent, and inflated, crushing the stent to the vessel wall. Angiography noted that the stent appeared to be well crushed to the vessel wall. 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 Key10582893
MDR Text Key208493791
Report Number2024168-2020-07990
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/15/2021
Device Model Number1550350-28
Device Catalogue Number1550350-28
Device Lot Number0060242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/24/2020 Patient Sequence Number: 1
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