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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
Catalog Number UNK RX SIERRA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 01/12/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: date estimated. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided. A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The additional device is filed under a separate medwatch report number.
 
Event Description
It was reported that (b)(6) 2021, a procedure was performed to treat the obtuse marginal artery without issues. A xience sierra stent was successfully implanted without issues. Approximately one week later, the patient experience contact dermatitis. On (b)(6) 2021, the patient underwent an additional procedure to treat the left anterior descending artery. A xience sierra stent was successfully implanted. However, after the procedure, the contact dermatitis worsened. The physician did not know what caused the allergic reaction. No additional information was provided.
 
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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 Key11287854
MDR Text Key230678081
Report Number2024168-2021-00916
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
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK RX SIERRA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/05/2021 Patient Sequence Number: 1
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