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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 1804225-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Myocardial Infarction (1969)
Event Date 12/08/2021
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. The reported patient effects of angina and myocardial infarction are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use (eifu) as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling. The other stent is filed under a separate medwatch report.
 
Event Description
It was reported that on (b)(6) 2021, the patient was admitted with st-segment elevation myocardial infarction (stemi). Three xience skypoint stents (2. 25x23mm, 2. 5x18mm, 2. 75x23mm) were implanted. On (b)(6) 2021, the patient was re-hospitalized with chest pain and stemi. Percutaneous coronary angioplasty was performed in two places, resolving the event and the patient was discharged home with no adverse sequela. 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 Key14190851
MDR Text Key289962529
Report Number2024168-2022-04400
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 Other,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1804225-23
Device Catalogue Number1804225-23
Device Lot Number1062141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2021
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: 04/22/2022 Patient Sequence Number: 1
Treatment
2.5X18, 2.75X23 XIENCE SKYPOINT STENTS
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