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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 1500350-18
Device Problems Material Separation (1562); Device Damaged by Another Device (2915)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/12/2021
Event Type  Injury  
Manufacturer Narrative
The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The 3. 5x12mm xience sierra device referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a de novo, 80% stenosed, mildly calcified and mildly tortuous vessel in the left anterior descending (lad) artery. The 2. 5x33mm xience sierra stent was deployed in the distal lad and the 3. 5x18mm xience sierra was deployed in the proximal lad. A 3. 5x12mm xience sierra was implanted in between the first two stents as it was noted there was an uncovered area between the first two stents. A 5. 5x8mm non-compliant balloon was used to post dilate as standard practice to optimize the proximal segment and during this post dilatation, it was found that the 3. 5x18 mm xience sierra in the proximal lad separated and a part had moved to the aorta under angiography. The separated portion of the stent was deliberately flared as much as possible in the aorta to try and reduce the struts sticking out. There was no reported adverse patient sequela. There was no significant delay in the procedure.
 
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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 Key12885878
MDR Text Key285986792
Report Number2024168-2021-10849
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSN
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,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1500350-18
Device Lot Number1070141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2021
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: 11/29/2021 Patient Sequence Number: 1
Treatment
2.5X33MM XIENCE SIERRA STENT; 3.5X12MM XIENCE SIERRA; 5.5X8 NC EMERGE BALLOON CATHETER
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