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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
Catalog Number 1550250-38
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Event Date 09/16/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation as it remains implanted. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The reported patient effects of angina, myocardial infarction and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures. The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition). Based on the case information and related record review, 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 design, manufacture or labeling of the device. The other implanted xience sierra stent is filed under a separate medwatch report.
 
Event Description
It was reported that on (b)(6) 2019 patient presented with an acute myocardial infarction. Two xience sierra stents were implanted in the mid to proximal left anterior descending (lad) coronary artery. On (b)(6) 2019, the patient presented with unstable angina and a myocardial infarction was diagnosed. Angiography was performed and confirmed thrombosis in both stents. Thrombectomy was performed with good results. Intravascular ultrasound (ivus) was performed and sub-optimal stent deployment was noted and treated with additional balloon dilatation. It was confirmed that patient had been compliant with dual anti-platelet therapy post implant of the two xience stents. No additional information was provided.
 
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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 Key9169019
MDR Text Key161809805
Report Number2024168-2019-12437
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227141
UDI-Public08717648227141
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
Type of Report Initial
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2019
Device Catalogue Number1550250-38
Device Lot Number8100841
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 Received09/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2018
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: 10/08/2019 Patient Sequence Number: 1
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