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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 1550250-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Stenosis (2263); Test Result (2695)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
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 angina and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. The additional xience sierra device referenced filed under separate medwatch report number.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2019, the patient presented with a recent non-st elevated myocardial infarction and a 70% stenosed lesion within the mid right coronary artery (rca). Pre-dilatation was performed within the mid rca and a 2. 5x38mm (1550250-38, 9020841) and a 2. 75x23mm (1550275-23, 8091141) xience sierra stent were implanted. Post-dilatation was performed. 0% residual stenosis was noted without a device issue reported. On (b)(6) 2020, during a follow-up, the patient reported experiencing ongoing, intermittent chest pain that was relieved with rest. As treatment, the patient's medication (nitroglycerine) was provided/adjusted. On (b)(6) 2020, during a follow-up, the patient presented with worsening chest pain. Per nuclear stress test, st segment depression was observed. On (b)(6) 2020, the patient continued to have chest pain. The patient was hospitalized and in-stent restenosis was observed in both rca, xience sierra stents. As treatment, angioplasty was performed on the 99% occluded lesion within the rca. The event resolved. 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 Key10454673
MDR Text Key204425471
Report Number2024168-2020-07117
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 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/17/2020
Device Model Number1550250-38
Device Catalogue Number1550250-38
Device Lot Number9020841
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 Received08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/26/2020 Patient Sequence Number: 1
Treatment
XIENCE SIERRA STENT
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