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

Catalog Number LSMU1351238

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

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

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2024).

Event Description

It was reported that prior to an angioplasty procedure, stent was allegedly found to be loose on the balloon catheter prior to entering the introducer sheath.The procedure was completed by using another device.There was no patient contact.

Event Description

It was reported that prior to an angioplasty procedure, stent allegedly dislocated.The procedure was completed by using another device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number.However, a device history record review was performed and the lot met all release criteria.Investigation summary: the lifestream device was returned.The balloon had not been inflated, the pleats, fold and stent crimp marks were still intact.The stent was present on the balloon but dislocated 4.5mm from the distal markerband.The result of the investigation is confirmed for the reported dislocated issue.The root cause for the reported dislodgement issue could not be determined based upon the available information received from the field communications and from the device 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.Use only diluted contrast medium for balloon inflation.Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent.For the contrast/saline solution, a ratio of 50/50 is recommended.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.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.Covered stent size selection 3.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.H10: d4 (expiry date: 05/2024), g3.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.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number.However, a device history record review was performed and the lot met all release criteria.Investigation summary: the lifestream device was returned.The balloon had not been inflated, the pleats, fold and stent crimp marks were still intact.The stent was present on the balloon but dislocated 4.5mm from the distal markerband.The result of the investigation is confirmed for the reported dislocated issue.The root cause for the reported dislodgement issue could not be determined based upon the available information received from the field communications and from the device 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.Use only diluted contrast medium for balloon inflation.Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the covered stent.For the contrast/saline solution, a ratio of 50/50 is recommended.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.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.Covered stent size selection: 3.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.H10: d4 (expiry date: 05/2024), g3.H11: b5, h6 (device, method, result, 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 Description

It was reported that prior to an angioplasty procedure, stent allegedly dislocated.The procedure was completed by using another device.There was no patient contact.

• 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: 12438982
• MDR Text Key: 270298081
• Report Number: 9616666-2021-00141
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSMU1351238
• Device Lot Number: CMFT0380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1