ABBOTT XIENCE V EVEROLIMUS ELUTING CORONARY STENT 1009542-15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-08 for ABBOTT XIENCE V EVEROLIMUS ELUTING CORONARY STENT 1009542-15 manufactured by Abbott Vascular.

Event Text Entries

[19685036] The patient was enrolled in the (b)(4) study. During the procedure to place the xience v stent in coronary artery, the patient experienced dyspnea, erythema, and shaking. The physician felt that this was due to the iv contrast that was used during the procedure. The patient was not known to have an iv contrast allergy prior to the procedure. Contrast used optiray 320. Manufacturer mallinckrodt inc. , (b)(4). Dose or amount: 3. 5 mm x 15 mm, 100 ml. Frequency: once. Route: #1 and #2 - intracardiac. Dates of use: (b)(6)2008. Diagnosis or reason for use: cad. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5011048
• MDR Report Key: 1379594
• Date Received: 2009-05-08
• Date of Report: 2009-05-08
• Date of Event: 2008-11-07
• Date Added to Maude: 2010-10-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ABBOTT XIENCE V EVEROLIMUS ELUTING CORONARY STENT
• Generic Name: XIENCE
• Product Code: NIQ
• Date Received: 2009-05-08
• Model Number: 1009542-15
• Lot Number: 7110641
• Device Expiration Date: 2008-11-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ABBOTT VASCULAR
• Manufacturer Address: SANTA CLARA CA 95054280 US 95054 2807

Device Sequence Number: 2

• Brand Name: OPTIRAY 320
• Generic Name: IOVERSOL INJECTION 68%
• Product Code: KTA
• Date Received: 2009-05-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: TYCO HEALTHCARE/MALLINCK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2009-05-08