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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1804350-15
Device Problem Material Rupture (1546)
Patient Problems Air Embolism (1697); Ischemia (1942)
Event Date 01/08/2022
Event Type  Injury  
Manufacturer Narrative
The stent remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a left anterior descending (lad) artery that is 90% stenosed. After pre-dilatation was performed with an unspecified balloon dilatation catheter the 3. 5x15mm xience skypoint stent delivery system (sds) was delivered and was inflated to 12 atmospheres; however, the balloon ruptured. Contrast medium flowed to the distal lad and air leaked at the same time causing a slow-flow. Nitroglycerin was administered and the blood flow stabilized. The stent was expanded properly with the kissing balloon technique to fully appose the stent into the vessel wall. There was no clinically significant delay reported. The physician¿s opinion was that this was a xience skypoint related interaction since there was no calcification in the lesion and there was no problem with the pre-dilatation. Prior to use, the catheter was soaked in saline. The device was prepped (air aspiration) outside the anatomy. No resistance was met when the protective sheath was removed. No resistance was met during advancement or removal. No additional information was provided.
 
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Brand NameXIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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 Key13416256
MDR Text Key284825296
Report Number2024168-2022-01067
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
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 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804350-15
Device Catalogue Number1804350-15
Device Lot Number108234A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2021
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: 02/01/2022 Patient Sequence Number: 1
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