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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 1804300-23
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2022
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. It is possible that the stent was not fully apposed to the vessel wall resulting in the reported difficulties; however this cannot be confirmed. The investigation determined a conclusive cause for the reported patient-device incompatibility recoil cannot be determined. The treatment appears to be related to the operational context of the procedure as post-dilatation was performed. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported the procedure was to treat a heavily calcified, heavily tortuous right coronary artery (rca). Atherectomy and pre-dilatation were performed. One skypoint stent was implanted in the distal rca, a 3. 0x23mm skypoint stent was deployed in the mid rca and another skypoint stent was implanted in the proximal rca. After the 3. 0x23 mm skypoint stent was deployed in the mid rca, the stent was observed to recoil, even after post dilatation at a higher pressure. Waist was noted and it was not seen during post dilatation but was seen after. 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 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 Key13560839
MDR Text Key285833366
Report Number2024168-2022-01718
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804300-23
Device Catalogue Number1804300-23
Device Lot Number1091641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2021
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: 02/18/2022 Patient Sequence Number: 1
Treatment
2 XIENCE SKYPOINT STENTS
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