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

Model Number	LSMU1350616
Medical Device Problem Codes	Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 12/2022).
Event or Problem Description
It was reported that during the stent procedure, the stent graft allegedly dislodged within the introducer sheath from the balloon delivery system.Another device and same sheath was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during the stent procedure in celiac curve through common femoral access, the stent graft allegedly dislodged within the introducer sheath from the balloon delivery system.Another device and same sheath was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was returned to the manufacturer for evaluation.The stent was returned on the balloon positioned over the proximal marker band.It was dislocated by 4.5mm towards the proximal bond.The investigation is confirmed for the reported dislodgement issue.The definitive root cause for the reported dislodgment issue could not be determined based upon information.Labeling review: 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.H10: d4 (expiry date: 12/2022),g4.H11: h6 (patient, method, result, conclusion).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.

• 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: 10263040
• Report Number: 9616666-2020-00051
• Device Sequence Number: 3066228
• Product Code: PRL
• UDI-Device Identifier: 05391522081468
• UDI-Public: (01)05391522081468
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSMU1350616
• Device Catalogue Number: LSMU1350616
• Device Lot Number: CMEN0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1