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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1550225-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Respiratory Failure (2484)
Event Date 12/04/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 death, hypotension, angina, cardio-respiratory arrest, cardiac failure and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic 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. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The other three xience sierra stents referenced are filed under separate medwatch report numbers.
 
Event Description
It was reported that the procedure was to treat a mildly tortuous and mildly calcified obtuse marginal branch, the diagonal branch and the left anterior descending artery. A 2. 25 x 12 mm xience sierra stent was implanted in the obtuse marginal branch, a 2. 25 x 18 mm xience sierra stent was implanted in the diagonal branch and a 2. 5 x 38 mm xience sierra stent was implanted in the left anterior descending (lad) artery without any issues. However, the patient complained of discomfort and then became hypotensive and experienced cardiac arrest. Therefore, cardiopulmonary resuscitation (cpr) was started and the patient was intubated. It was noted that there was no flow in the vessels that were stented due to thrombus. Therefore, balloon angioplasty was performed in the proximal circumflex, diagonal and lad arteries. Aspiration was performed to remove the thrombus and a 2. 5 x 38 mm xience sierra stent was implanted in the distal lad. Cpr continued; however, the patient expired that same day on (b)(6) 2018. No additional information was provided.
 
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Brand NameXIENCE SIERRA 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 Key8197825
MDR Text Key131466193
Report Number2024168-2018-10045
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
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/12/2019
Device Catalogue Number1550225-12
Device Lot Number8072741
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 Received12/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
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: 12/26/2018 Patient Sequence Number: 1
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