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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
Catalog Number 1500350-15
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified right coronary artery that was significantly stenosed.A 3.5x15mm xience sierra was advanced to the lesion and when inflated at an unspecified atmosphere and inflation, a leak and crack was noted at the hub.The stent was not implanted.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
 
Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported side arm/hub break and leak/splash were 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 investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Na.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified right coronary artery that was significantly stenosed.A 3.5x15mm xience sierra was advanced to the lesion and when inflated at an unspecified atmosphere and inflation, a leak and crack was noted at the hub.The stent was not implanted.There was no adverse patient effects and no clinically significant delay.Additional information received from the account subsequent to filing the initial report stating that after the device was removed from the anatomy, it was cleaned with saline and the protective sheath was intentionally added back on.No additional information was provided.
 
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Brand Name
XIENCE SIERRA
Type of Device
DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key10209195
MDR Text Key198609997
Report Number2024168-2020-05412
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/24/2021
Device Catalogue Number1500350-15
Device Lot Number8071341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2020
Date Manufacturer Received07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INDEFLATOR
Patient Age62 YR
Patient Weight24
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