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

Model Number	LSMU1350758
Medical Device Problem Codes	Retraction Problem (1536); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Stenosis (2263); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation, however photos have been provided.The investigation of the reported event is currently underway.(expiry date: 07/2021).
Event or Problem Description
It was reported that the stent was present in the right external iliac artery, the device allegedly dislodged from the balloon.It was further reported that the stent could not be retrieved and the patient found to be bleeding.The patient status is unknown.
Event or Problem Description
It was reported that the stent was present in the right external iliac artery, the device allegedly dislodged from the balloon.It was further reported that the stent could not be retrieved and the patient found to be bleeding.The patient status is unknown.
Additional Manufacturer Narrative
H10: this report is being submitted to communicate that this file is a duplicate.The event is captured under report number 9616666-2020-00040.No further reports will be submitted under 9616666-2020-00038.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the stent was present in the right external iliac artery, the device allegedly dislodged from the balloon.It was further reported that the stent could not be retrieved and the patient found to be bleeding.The patient status is unknown.

• Brand Name: LIFESTREAM
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 10157202
• Report Number: 9616666-2020-00038
• Device Sequence Number: 11630005
• Product Code: PRL
• UDI-Device Identifier: 05391522081154
• UDI-Public: (01)05391522081154
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSMU1350758
• Device Catalogue Number: LSMU1350758
• Device Lot Number: CMCV0405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 09/03/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/09/2020; 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 60