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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1011710-23
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Myocardial Infarction (1969); Pulmonary Edema (2020); Test Result (2695)
Event Date 08/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 on (b)(6) 2013, a 3. 5x23mm and a 3. 5x18mm xience prime stent were successfully implanted in the left main complex (left main, ostial left anterior descending (lad), ostial/proximal left circumflex (lcx) coronary arteries). On (b)(6) 2018, the patient had chest pain and went into cardiac arrest and while going to the hospital. The patient was hospitalized and closed cardiac massage (cpr) was provided. A myocardial infarction was diagnosed. During this hospitalization, the patient had hypotensive episodes and pulmonary edema. Medical treatment was provided and a myocardial perfusion scan was provided displaying ischemic dilatation with impaired left ventricular dysfunction. No new restenosis was reported. The event resolved. No additional information was provide regarding this issue.
 
Manufacturer Narrative
(b)(4). There was no reported device malfunction and the product was not returned as the stent remains in the anatomy. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. It should be noted that the reported patient effect of angina, hypotension, ischemia, myocardial infarction and pulmonary edema are listed in the xience prime, xience prime small vessel, and xience prime everolimus eluting coronary stent system instructions for use (ifu) as a known patient effects of coronary stenting procedures. Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
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Brand NameXIENCE PRIME 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 Key8021798
MDR Text Key125590454
Report Number2024168-2018-08297
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/21/2015
Device Catalogue Number1011710-23
Device Lot Number3050942
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 Received11/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
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: 10/30/2018 Patient Sequence Number: 1
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