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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 1804350-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969)
Event Date 10/28/2021
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 myocardial infarction and hypertension are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use 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.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
It was reported that on 10/19/2021 the patient had a 3.50x23 mm xience skypoint stent implanted.On (b)(6) 2021 and (b)(6) 2021, the patient was re-hospitalized due to hypertensive heart and acute myocardial infarction.The type of treatment was assistance respiratory ventilation and there was no adverse patient sequela.No additional information was provided.
 
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Brand Name
XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Type of Device
DRUG 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 Key14022489
MDR Text Key288678341
Report Number2024168-2022-03613
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233418
UDI-Public08717648233418
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 Physician
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/22/2023
Device Model Number1804350-23
Device Catalogue Number1804350-23
Device Lot Number1031642
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/17/2022
Initial Date FDA Received04/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Disability; Required Intervention;
Patient Age62 YR
Patient SexFemale
Patient Weight124 KG
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