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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 1804275-12
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
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 was unable to determine a conclusive cause for the reported material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity. The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigation's have been established for potential causes. There was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties. Based on the information provided, a definitive cause for the reported material rupture cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the patient presented with an acute myocardial infarction (ami) and the procedure was to treat the left anterior descending (lad) coronary artery with moderate calcification, moderate tortuosity and 90% stenosis. Intravascular ultrasound (ivus) was performed and the 2. 75x12 mm xience skypoint stent was placed. The balloon was inflated once at 5 to 6 atmospheres (atm) for 5 seconds and ruptured. The stent delivery system was removed without resistance and the stent was confirmed with angiography to be deployed. Post-dilatation was performed about 3 times with a 2. 75x10mm balloon and it was confirmed with ivus that the stent was completely apposed and the procedure was completed. It was reported that the stent easily crossed and was apposed as it was short length stent. There were no adverse patient effects and there was no clinically significant delay in the procedure. 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 Key12214891
MDR Text Key263142611
Report Number2024168-2021-06379
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804275-12
Device Catalogue Number1804275-12
Device Lot Number0090241
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 Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/22/2021 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: HEARTRAIL 6F; GUIDE WIRE: SION BLUE
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