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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550300-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Tachycardia (2095); Cardiogenic Shock (2262); Respiratory Failure (2484); Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446)
Event Date 05/17/2021
Event Type  Death  
Manufacturer Narrative
The stent remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional 3. 0x23mm xience sierra referenced and the unk xience device referenced iare filed under separate medwatch report numbers.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2021, a percutaneous coronary intervention (pci) was performed on the proximal left anterior descending (lad), left main (lm), and left circumflex (lcx) coronary arteries. Pre-dilatation was performed without complication. A 3. 0x48mm abt ng des was unable to be delivered past the elbow due to anatomy. The abt ng des was successfully withdrawn. A guide-liner was placed and a non-flow limiting dissection of the lm was observed. An intra-aortic balloon pump (iabp) was placed, the patient was intubated and cardiovascular was consulted, recommending a stent to the lm. In replacement, a 2. 5x23mm and a 3. 0x23mm xience sierra stents were implanted in the proximal lad without a device issue reported. Reportedly, the second stent was observed mal-deployed post-implant. Post-deployment of the lad stents, a small dissection in the proximal cx was observed. As treatment for the dissection, a 3. 0x28mm xience stent was placed from the lm to the proximal lcx. Post-deployment, a lm dissection was observed. As treatment, a 3. 25x18mm xience stent was placed in the lm without an issue reported. As additional treatment, an unspecified xience stent delivery system (sds) attempted to cross, however, was unable to cross. During sds removal, the stent dislodged from the delivery system into the guide catheter. The patient had been intubated, medications were provided, and the patient was transferred to surgery for an emergent coronary artery bypass graft (cabg). Intravenous fluids/medication, blood/blood products and platelet transfusions were provided. Chest x-rays had been performed showing mild pulmonary edema. The patient had become tachycardic and hypotensive. Medications were provided. The patient had low cardiac output syndrome and had gone into cardiogenic shock with marked acidosis and elevated pro-b-type natriuretic peptide labs. Per echocardiogram, the patient was in severe post-operation left ventricular (lv) dysfunction. An impella had been placed via another percutaneous procedure. Elevated cardiac enzymes were observed without a myocardial infarction diagnosis reported. Medications and blood/blood product transfusions were provided. Following discussion with the physician, the family withdrew care. Medications and impella device were discontinued. On (b)(6) 2021, the patient expired due to cardiogenic shock and respiratory failure. Per physician, the events were unrelated to the 3. 0x48mm abt ng des device that failed to cross. Per physician, the events were related to the procedure as cascading events from the dissection. No additional information was provided regarding this issue.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT 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 Key11958686
MDR Text Key254873558
Report Number2024168-2021-04758
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/11/2022
Device Model Number1550300-28
Device Catalogue Number1550300-28
Device Lot Number0110542
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 Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
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: 06/08/2021 Patient Sequence Number: 1
Treatment
TWO XIENCE SIERRA STENTS
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