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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550300-38
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis (2100); Respiratory Failure (2484)
Event Date 01/13/2020
Event Type  Death  
Manufacturer Narrative
The 3. 5x38mm xience sierra stent, referenced is being filed under a separate medwatch report number. The stent remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on the proximal right coronary artery (rca), 70% stenosed lesion. Pre-dilatation and atherectomy was performed on the rca. Following rotablator use, a proximal rca dissection occurred. Reportedly, a 3. 5x15mm xience sierra stent was implanted at the rca ostium due to this dissection. There was no underexpansion confirmed or reported and no device malfunction. As planned, 3. 0x38mm and 3. 5x38mm xience sierra stents were implanted in the proximal rca. Post-dilatation was performed using a non-compliant balloon. The diameter stenosis was reduced to 25% with timi flow iii. On (b)(6) 2020, the patient was hospitalized for severe substernal chest pain. Medications including nitroglycerin had been provided. Elevated troponin and a st elevated myocardial infarction (stemi) was diagnosed. Per imaging, the ostial-proximal rca was patent, however, the proximal rca with the 3. 0x38mm and 3. 5x38mm xience sierra stents, to the distal rca, was occluded with 100% thrombus. Reportedly, both the 3. 0x38mm and 3. 5x38mm xience sierra stents were underexpanded. High pressure balloon angioplasty was performed, resolving the occlusion. On (b)(6) 2020, the patient passed away due to respiratory failure, pneumonia, and the stemi, related to this hospitalization. No additional information was provided regarding this issue.
 
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Brand NameXIENCE SIERRA
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 Key9713884
MDR Text Key179510172
Report Number2024168-2020-01499
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/16/2020
Device Model Number1550300-38
Device Catalogue Number1550300-38
Device Lot Number9091141
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 Received02/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2019
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: 02/14/2020 Patient Sequence Number: 1
Treatment
2 XIENCE SIERRA STENTS; 6 FRENCH GUIDE CATHETER
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