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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1125300-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Death (1802); Dyspnea (1816); Myocardial Infarction (1969); Pulmonary Edema (2020)
Event Date 09/02/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the proximal circumflex artery with a 3. 0 x 23 mm xience alpine stent. Approximately 3 months post stenting procedure, the patient had complaints of dyspnea and chest heaviness, diagnosed as pulmonary edema. Cardiac enzymes were elevated and myocardial infarction was diagnosed. Unspecified treatment was provided. Cardiac catheterization was performed. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The reported patient effect of death is listed in instructions for use xience alpine everolimus eluting coronary stent systems as a known patient effect of coronary stenting procedures. A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined; however, based on the information, the reported death is not related to the device, but is related to progression of disease.
 
Event Description
Subsequent to the follow-up # 1 medwatch report, the following information was provided: the patient was discharged to home on (b)(6) 2018, on hospice care, after hospitalization for myocardial infarction. On (b)(6) 2018, the patient died of causes related to progression of disease. Per the physician, the death is not related to the implanted stent. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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, dyspnea, myocardial infarction and pulmonary edema are listed in instructions for use xience alpine everolimus eluting coronary stent systems 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. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial report, additional information was provided, which indicated that on (b)(6) 2018, the patient was re-hospitalized. Treatment for the pulmonary edema was dialysis. Cardiac catheterization was performed and a non-abbott stent was implanted. No additional information was provided.
 
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Brand NameXIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7916986
MDR Text Key121989511
Report Number2024168-2018-07496
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1125300-23
Device Lot Number8012041
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 Received01/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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: 09/27/2018 Patient Sequence Number: 1
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