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

Catalog Number LSM1350626

Device Problems Difficult to Open or Remove Packaging Material (2922); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation.Therefore, the result of the investigation is inconclusive for the reported packaging and dislodgement issues.The root cause for the reported packaging and dislodgement issues could not be determined based upon the available information received from the field communications.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: covered stent size selection select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation carefully remove the selected device from the package.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.The catalog number identified has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified.(expiry date: 10/2023).Device not returned.

Event Description

It was reported that during the preparation of stent placement procedure, the stent allegedly dislodged.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that during the preparation of stent placement procedure, the stent loosened by removing the protective plastic.It was further reported that the stent allegedly dislodged.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream products that are cleared in the us.The pro code and 510 k number for the lifestream products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation.Therefore, the result of the investigation is inconclusive for the reported packaging and dislodgement issues.The root cause for the reported packaging and dislodgement issues could not be determined based upon the available information received from the field communications.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: covered stent size selection ¿ select a covered stent diameter that is approximately 5%-20% larger than the largest reference vessel diameter at the proximal or distal target site.Refer to the sizing table on the packaging label for appropriate selection of the covered stent diameter and length.Endovascular system preparation 4.Carefully remove the selected device from the package.5.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system h10: b5, d4 (expiry date: 10/2023), g3 h11: section a through f ¿ the information provide by bd represents all 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.H3 other text : device not returned.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 12414746
• MDR Text Key: 270590183
• Report Number: 9616666-2021-00139
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081475
• UDI-Public: (01)05391522081475
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350626
• Device Lot Number: CMEY0166
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1