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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE DRUG ELUTING CORONARY STENT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK RX XIENCE
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
The unique device identifier (udi) is unknown because the part and lot numbers were not provided. The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The nc trek balloon dilatation catheter referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was performed to treat a heavily calcified, heavily tortuous lesion in the mid to proximal left anterior descending (lad) artery. A 4. 0mm xience stent was deployed when it was noted via intravascular ultrasound (ivus) that the stent was under deployed. The physician then used a 5. 0x12mm nc trek balloon dilatation catheter (bdc) in an attempt to further post dilate the xience stent. During removal of the nc trek, the device was reportedly either caught on a stent strut or on the guide liner, some force was applied, and the shaft snapped. The balloon was pulled into the guiding catheter and the device was fully removed all at once. The device was in two pieces upon removal. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE DRUG ELUTING CORONARY STENT
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 Key9803256
MDR Text Key182546334
Report Number2024168-2020-02115
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RX XIENCE
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 Received03/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/06/2020 Patient Sequence Number: 1
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