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

Catalog Number LSM1350637

Device Problems Break (1069); Positioning Failure (1158); Inflation Problem (1310); Retraction Problem (1536); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 11/22/2020

Event Type  malfunction  

Manufacturer Narrative

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 510k number for the lifestream products is identified.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: 04/2023; device pending return.

Event Description

It was reported that during a stent placement procedure via right renal artery, balloon allegedly unable to inflate and failed to retract.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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.The result of the investigation is inconclusive for the reported retraction, inflation, device incompatibility and detachment issues.The root cause could not be determined based upon the available information.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used in the renal artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.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 that during a stent placement procedure via right renal artery, balloon was allegedly unable to inflate successfully.There was difficulty retracting the device and the guidewire stuck.It was further reported that the delivery system was torn off at the proximal end.Another balloon was used to complete the procedure.There was no reported patient injury.

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 510k number for the lifestream products is identified in d2 and g5.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 returned for evaluation.The result of the investigation is inconclusive for the reported retraction, inflation and detachment issues.The device was partially returned in poor condition.The balloon and tip section was not returned and appeared to have been broken from the device.The investigation is confirmed for the reported device incompatibility issue.There was a 0.035" guidewire returned within the device that could not be removed during the evaluation.This was due to the shaft of the device been badly accordioned in three locations.The damage and missing catheter section is indicative of excessive force been used likely during the retraction of the device during the procedure.The root cause for the reported retraction, inflation, device incompatibility and detachment issues 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 event description states that the lifestream was being used in the renal artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries warnings: should excessive resistance be felt at any time during the insertion process, do not force passage.Attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.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 introduction of the endovascular system and placement of the covered stent advance the endovascular system over the guidewire into the introducer sheath.H10: d4 (expiry date: 04/2023).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 : see h10.

Event Description

It was reported that during a stent placement procedure via right renal artery, balloon was allegedly unable to inflate successfully.There was difficulty retracting the device and the guidewire stuck.It was further reported that the delivery system was torn off at the proximal end.Another balloon was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure via right renal artery, balloon was allegedly unable to inflate successfully.There was difficulty retracting the device and the guidewire stuck.It was further reported that the delivery system was torn off at the proximal end.Another balloon was used to complete the procedure.There was no reported patient injury.

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 510k number for the lifestream products is 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 returned for evaluation.The result of the investigation is inconclusive for the reported retraction, inflation and detachment issues.The device was partially returned in poor condition.The balloon and tip section was not returned and appeared to have been broken from the device.The investigation is confirmed for the reported device incompatibility issue.There was a 0.035" guidewire returned within the device that could not be removed during the evaluation.This was due to the shaft of the device been badly accordioned in three locations.The damage and missing catheter section is indicative of excessive force been used likely during the retraction of the device during the procedure.The root cause for the reported retraction, inflation, device incompatibility and detachment issues 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 event description states that the lifestream was being used in the renal artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries warnings: should excessive resistance be felt at any time during the insertion process, do not force passage.Attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.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.Introduction of the endovascular system and placement of the covered stent advance the endovascular system over the guidewire into the introducer sheath.H10: d4 (expiry date: 04/2023), 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 : see h10.

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.A manufacturing review was carried out and there was nothing to indicate a manufacturing related issue.Investigation summary: the device was partially returned in poor condition.The balloon and tip section was not returned and appeared to have been broken from the device.The investigation is confirmed for the reported device incompatibility issue.There was a 0.035" guidewire returned within the device that could not be removed during the evaluation.This was due to the shaft of the device been badly accordioned in three locations.The damage and missing catheter section is indicative of excessive force been used likely during the retraction of the device during the procedure.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.The investigation is inconclusive for the reported retraction, inflation and detachment issues.The root cause for the reported retraction, inflation, device incompatibility and detachment issues could not be determined based upon the available information received from the field communication and sample evaluation.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream was being used in the renal artery.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries warnings: ¿ should excessive resistance be felt at any time during the insertion process, do not force passage.¿ attempts to retract the covered stent into the sheath/guiding catheter may result in dislodgement and embolization of the covered stent.Maintain guidewire placement across the lesion and withdraw the endovascular system only until the proximal end of the covered stent is aligned with the tip of the sheath/guiding catheter.Do not attempt to remove an unexpanded covered stent through the sheath/guiding catheter.Remove the sheath/guiding catheter and endovascular system as a single unit.Attempting to remove an unexpanded covered stent by pulling it back into the sheath/guiding catheter may result in stent dislodgement.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 introduction of the endovascular system and placement of the covered stent ¿ advance the endovascular system over the guidewire into the introducer sheath.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 : see h10.

Event Description

It was reported that during a stent placement procedure via right renal artery, balloon was allegedly unable to inflate successfully.There was difficulty retracting the device and the guidewire stuck.It was further reported that the delivery system was torn off at the proximal end.Another balloon was used to complete the procedure.There was no reported patient injury.

• 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11025368
• MDR Text Key: 222412966
• Report Number: 9616666-2020-20031
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350637
• Device Lot Number: CMES0222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 75 KG