LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM1350837

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-03 for LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM1350837 manufactured by Clearstream Technologies Ltd..

MAUDE Entry Details

• Report Number: 9616666-2019-00066
• MDR Report Key: 8665021
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-06-03
• Date of Report: 2019-06-14
• Date of Event: 2019-05-08
• Date Mfgr Received: 2019-06-13
• Device Manufacturer Date: 2018-11-05
• Date Added to Maude: 2019-06-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Event Location: 3
• Manufacturer Contact: JUDITH LUDWIG
• Manufacturer Street: 1625 W 3RD ST.
• Manufacturer City: TEMPE AZ 85281
• Manufacturer Country: US
• Manufacturer Postal: 85281
• Manufacturer Phone: 4803032689
• Manufacturer G1: CLEARSTREAM TECHNOLOGIES LTD.
• Manufacturer Street: MOYNE UPPER
• Manufacturer City: ENNISCORTHY, CO. WEXFORD
• Manufacturer Country: EI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Generic Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Product Code: PRL
• Date Received: 2019-06-03
• Returned To Mfg: 2019-05-17
• Catalog Number: LSM1350837
• Lot Number: CMCY0045
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CLEARSTREAM TECHNOLOGIES LTD.
• Manufacturer Address: MOYNE UPPER ENNISCORTHY, CO. WEXFORD EI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-03