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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 1550300-23
Device Problems Inflation Problem (1310); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Device Damaged by Another Device (2915); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/10/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. 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 and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the anatomy and previously implanted stent during advancement causing the reported difficulty to advance and device damaged another (previously expanded stent mangled). An attempt was made to inflate the balloon; however, the reported interaction with the anatomy and/or previously implanted stent likely caused reported material rupture and subsequent inflation problems with activation failure. The device was inflated to nominal pressure expanding the distal portion of the stent prior to the reported rupture. The partial expansion and reported interaction with the mangled previously expanded stent likely caused the reported stent dislodgement and foreign body in patient. During removal resistance was felt likely due to the inability of the ruptured balloon to fully deflate prior to removal causing the reported difficulty to remove and subsequent material separation. The separation occurred outside of the anatomy and the device was removed without issue. An attempt was made to advance a balloon catheter; however, they were unable to re-engage and the artery was left untreated. There is no indication of a product quality issue with respect to manufacture, design or labeling. Na.
 
Event Description
It was reported the procedure was to treat a de novo lesion in the mid circumflex coronary artery. When advancing the 3. 0x23 mm xience sierra stent delivery system (sds), resistance was felt with the anatomy and the stent got caught on a previously implanted stent, possibly mangling the previously implanted stent. An attempt was made to inflate the balloon; however, the balloon did not inflate properly. The balloon only inflated on the distal end. It is suspected the proximal end of the balloon leaked. The stent did not deploy and dislodged inside the previously implanted stent. Resistance was felt during removal of the sds. Once the sds was outside of the anatomy, the proximal shaft separated. An attempt was made to get back in the vessel with a balloon to try to expand the stent struts inside the previously implanted stent; however, the artery could not be re-engaged, therefore the lesion was left untreated. 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 Key12081691
MDR Text Key263396837
Report Number2024168-2021-05518
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 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/20/2022
Device Model Number1550300-23
Device Catalogue Number1550300-23
Device Lot Number0121641
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 Received06/14/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/28/2021 Patient Sequence Number: 1
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