MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR STENT GRAFT

Catalog Number UNKNOWN LIFESTREAM OUS

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Aneurysm (1708); Injury (2348)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: lindström, david & mani, kevin & lundberg, göran & wanhainen, anders.(2019).Bridging stent grafts in fenestrated and branched endovascular aortic repair: current practice and possible complications.The journal of cardiovascular surgery.60.10.23736/s0021-9509.19.10942-1.

Event Description

It was reported in an article in the journal of cardiovascular surgery titled " bridging stent grafts in fenestrated and branched endovascular aortic repair: current practice and possible complications " that two months after the placement of the four fenestrated endovascular aortic repair (fevar) stent graft, a postoperative computed tomography (ct) demonstrated a type iiic endoleak from the right renal fenestration.An additional intervention was required for relining the right renal artery.The patient status was not provided.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR STENT GRAFT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9234531
• MDR Text Key: 170793934
• Report Number: 9616666-2019-00138
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN LIFESTREAM OUS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR