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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 1550350-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Prolapse (2475); Vascular Dissection (3160)
Event Date 09/11/2019
Event Type  Injury  
Manufacturer Narrative
The patients demographics were obtained from the index procedure date. 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. It should be noted that the reported patient effects of prolapse and dissection are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2019, a percutaneous intervention was performed on the proximal left anterior descending (lad) coronary artery, moderately calcified lesion with in-stent restenosis (stent not specified). Pre-dilatation was performed and a 3. 5x28mm xience sierra stent (1550350-28, 9052341) was implanted in the proximal lad. Following, an intra-stent plaque protrusion was observed, left untreated. A distal stent edge dissection had also occurred with additional dilatation performed following. 0% residual stenosis with timi flow iii was observed following. On (b)(6) 2021, the patient was admitted to the hospital with midsternal pressure on exertion, along with dyspnea. Imaging was performed and the ostial lad had 90% stenosis with 95% mid in-stent restenosis. The right coronary artery (rca) was occluded with collaterals. The 3. 5x28mm xience sierra stent had remained patent, without restenosis. On (b)(6) 2021, a coronary artery bypass graft (cabg) was performed. A graft was placed to the lad and posterior descending coronary artery. Per physician, the event starting on (b)(6) 2021 was unrelated to the xience sierra stent and unrelated to the index procedure. There was no restenosis observed in the xience sierra stent and there was no device malfunction. 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 Key12516801
MDR Text Key272870381
Report Number2024168-2021-08476
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 health professional,study
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/29/2020
Device Model Number1550350-28
Device Catalogue Number1550350-28
Device Lot Number9052341
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 Received09/02/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/22/2021 Patient Sequence Number: 1
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