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

Catalog Number LSM0801058

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2021

Event Type  Death  

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 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.The catalog number identified has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510 k number for the lifestream are identified.Date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.Expiry date: 01/2024.

Event Description

It was reported during the stent implantation procedure through the right groin, the device allegedly dislodged from the balloon.The patient experienced bilateral pelvic artery occlusion and subsequently died three days after procedure.

Manufacturer Narrative

H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510 k number for the lifestream 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.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned to the manufacturer for evaluation.Therefore, the result of the investigation is inconclusive for the reported balloon dislodgement issue.A definitive root cause could not be determined based upon the available information.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the lifestream stent intended implantation site was the thoracic aorta due to penetrating atherosclerotic ulcer (pau).This is off label use of the device.Section b indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Precautions: the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.Prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure covered stent misplacement during placement procedure directions for use: site access and preparation using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.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 important: do not apply positive pressure to the balloon.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.H10: d4 (expiry date: 01/2024), 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.

Event Description

It was reported during the stent implantation procedure through the right groin, the device allegedly dislodged from the balloon.The health care provider was able to manage and got the procedure under control.It was reported, as a result of manipulation of the 22 f sheath, the patient got bilateral pelvic artery occlusion and deceased three days later.

Manufacturer Narrative

H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestream that are cleared in the us.The pro code and 510 k number for the lifestream 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.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned to the manufacturer for evaluation.Therefore, the result of the investigation is inconclusive for the reported balloon dislodgement issue.A definitive root cause could not be determined based upon the available information.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the lifestream stent intended implantation site was the thoracic aorta due to penetrating atherosclerotic ulcer (pau).This is off label use of the device.Section b indication for use: the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Precautions the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.Prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Potential patient/device adverse effects that may occur include, but are not limited to, the following: covered stent dislodgement from balloon during tracking procedure covered stent misplacement during placement procedure directions for use: site access and preparation: using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.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.Important: do not apply positive pressure to the balloon.Attach the prefilled inflation device to the inflation lumen of the catheter hub, ensuring no air bubbles remain at the catheter connection.Verify that the covered stent is still centered between the two radiopaque markers on the balloon catheter.H10: d4 (expiry date: 01/2024).H11: b5, h6 (method).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.

Event Description

It was reported during the stent implantation procedure through the right groin, the device allegedly dislodged from the balloon.The health care provider was able to manage and got the procedure under control.It was reported, as a result of manipulation of the 22 f sheath, the patient got bilateral pelvic artery occlusion and deceased three days later.

• 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: 12187492
• MDR Text Key: 262147129
• Report Number: 9616666-2021-00112
• Device Sequence Number: 1
• Product Code: PRL
• 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,Followup
• Report Date: 09/20/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: LSM0801058
• Device Lot Number: CMFP0148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 09/08/2021
• Supplement Dates FDA Received: 08/13/2021; 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR