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

Model Number LSMU1350837

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Vascular Dissection (3160)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will 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.The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.

Event Description

It was reported that during a stent graft placement procedure via left brachial access the stent graft allegedly dislodged while retracting the delivery system.Furthermore, a snare was used to retrieve the device and the subclavian artery was dissected.Reportedly, a new device was used to complete the procedure.The current patient status is unknown.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8461738
• MDR Text Key: 140225283
• Report Number: 9616666-2019-00033
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081222
• UDI-Public: (01)05391522081222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU1350837
• Device Catalogue Number: LSMU1350837
• Device Lot Number: CMCU0470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2019
• 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: 78 YR
• Patient Weight: 68