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

Model Number LSMU0800938

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 02/28/2020

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.(expiry date: 10/2022).

Event Description

It was reported that during preparation for a kissing stent graft placement in the moderately calcified common iliac via femoral tracking, air bubbles were allegedly identified; however, the healthcare provider (hcp) continued with the procedure.During treatment, a rupture was allegedly identified, preventing full stent graft expansion.As a result, the hcp began to remove the delivery system and the stent graft dislodged from the balloon.Reportedly, an additional pta balloon was used to retract the dislodged stent graft into the common femoral artery and a surgical cutdown procedure was required to retrieve the stent graft altogether.Another stent of a different manufacturer was used to complete the procedure.The patient is reportedly stable.

• 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 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: 9880960
• MDR Text Key: 190602267
• Report Number: 9616666-2020-00021
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081246
• UDI-Public: (01)05391522081246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU0800938
• Device Catalogue Number: LSMU0800938
• Device Lot Number: CMDY0425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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