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

Model Number	LSMU1350526
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
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: 09/2023).Device pending return.
Event or Problem Description
It was reported during a procedure, the stent allegedly dismounted from the balloon.There was no reported patient injury.
Event or Problem Description
It was reported during a procedure, the stent allegedly dismounted from the balloon.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot.However, a 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 lifestream device was returned.The stent was returned lodged within the sleeve.The sleeve was partially removed from the device.The distal taper of the sleeve was slightly deformed.The lifestream balloon had not been inflated.The pleats, folds and stent crimp indentations were present.The result of the investigation is confirmed for the reported stent dislodgement issue.The root cause for the reported dislodgement issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings: do not use if packaging/pouch is damaged.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.This device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers.Crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.Store in a cool and dry place.Keep away from sunlight.Potential adverse events: covered stent dislodgement from balloon during tracking procedure.H10: d4 (expiry date: 09/2023).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.H3 other text : see h10.
Event or Problem Description
It was reported that preparation of an stent graft placement, the stent graft allegedly dismounted from the balloon.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot.However, a 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 lifestream device was returned.The stent was returned lodged within the sleeve.The sleeve was partially removed from the device.The distal taper of the sleeve was slightly deformed.The lifestream balloon had not been inflated.The pleats, folds and stent crimp indentations were present.The result of the investigation is confirmed for the reported stent dislodgement issue.The root cause for the reported dislodgement issue could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings: ¿ do not use if packaging/pouch is damaged.¿ 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.¿ this device has not been tested for use in overlapped conditions with stents or covered stents from other manufacturers.¿ crossing the implant with catheters or other adjunct devices can result in covered stent dislodgement or damage.¿ store in a cool and dry place.Keep away from sunlight.Potential adverse events: ¿ covered stent dislodgement from balloon during tracking procedure 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.H3 other text : see h10.

• 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
• 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: 12632523
• Report Number: 9616666-2021-00166
• Device Sequence Number: 11605513
• Product Code: PRL
• UDI-Device Identifier: 05391522080980
• UDI-Public: (01)05391522080980
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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: LSMU1350526
• Device Catalogue Number: LSMU1350526
• Device Lot Number: CMEX0384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 11/03/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 10/22/2021; 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown