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

Model Number	LSMU1350626
Medical Device Problem Codes	Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
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 (07/2022).
Event or Problem Description
It was reported that during a stent placement, the device allegedly got stuck and was not able to load through the introducer sheath and failed to advance.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this was the first complaint reported for this lot number.Based on the severity and lot quantity the number of events is below the acceptable quality level.Investigation summary: the sample was returned for evaluation.The balloon had been inflated and there was no stent returned with the device.The investigation is inconclusive for the reported device incompatibility and failure to advance issues.The definitive root cause for the reported device incompatibility and failure to advance issues could not be determined based upon information received.Labeling review: the instructions for use 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 (07/2022), g4.H11: h6(results, 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.
Event or Problem Description
It was reported that during a stent placement, the device allegedly got stuck and was not able to load through the introducer sheath and failed to advance.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was provided and a lot history review was performed.Investigation summary: the sample was returned for evaluation.The balloon had been inflated and there was no stent returned with the device.The investigation is inconclusive for the reported device incompatibility and failure to advance issues.The definitive root cause for the reported device incompatibility and failure to advance issues could not be determined based upon information received.Labeling review: the instructions for use 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 (07/2022).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 during a stent placement, the device allegedly got stuck and was not able to load through the introducer sheath and failed to advance.There was no reported patient injury.

• 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: 10325063
• Report Number: 9616666-2020-00078
• Device Sequence Number: 16702949
• Product Code: PRL
• UDI-Device Identifier: 05391522081055
• UDI-Public: (01)05391522081055
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/16/2020

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: LSMU1350626
• Device Catalogue Number: LSMU1350626
• Device Lot Number: CMDV0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 09/15/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/08/2020; 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 58