LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM1350938

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-10-02 for LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT LSM1350938 manufactured by Clearstream Technologies Ltd..

MAUDE Entry Details

• Report Number: 9616666-2019-00102
• MDR Report Key: 9148379
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2019-10-02
• Date of Report: 2019-11-12
• Date of Event: 2019-05-24
• Date Mfgr Received: 2019-11-12
• Device Manufacturer Date: 2017-12-13
• Date Added to Maude: 2019-10-02
• 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: 1415 W. 3RD STREET
• 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 N A
• Manufacturer Country: EI
• Manufacturer Postal Code: N A
• 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: 2019-10-02
• Catalog Number: LSM1350938
• Lot Number: CMBZ0220
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CLEARSTREAM TECHNOLOGIES LTD.
• Manufacturer Address: MOYNE UPPER ENNISCORTHY, CO. WEXFORD N A EI N A

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-02