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 04/19/2023

Event Type  malfunction  

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: 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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2023).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: device pending return.

Event Description

It was reported that during preparation of a stent graft procedure in right renal artery, the stent graft was found inlayed in the middle of the balloon marker band and allegedly difficult to remove the protector.The stent moved with the protector and was separated from the balloon.The procedure was completed by 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 fifth complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the lifestream device was returned for evaluation.The stent was positioned on the balloon and over the distal cone, it was dislodged by 9mm.The sleeve was present on the catheter and stent and past the distal tip by 26mm.No damage was noted.There was no evidence to indicate the balloon had been previously inflated, its pleats, folds and crimp indentations were intact.The result of the investigation is unconfirmed for the reported difficulty to remove sleeve issue.The result of the investigation is confirmed for the reported stent dislodgment issue.The result of the investigation is unconfirmed for the reported difficulty to remove sleeve issue.The sleeve inner diameter was measured using in house pin gauge set and was compliant.The root cause for the reported stent dislodgment and difficulty to remove sleeve issue could not be determined based upon the available information received from the field communications, device evaluation and images review.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: indication for use the lifestream¿ balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Warnings ¿ do not use if packaging/pouch is damaged.¿ use the device prior to the use by date specified on the package.Storage store in a cool, dry place.Keep away from sunlight.Use the device prior to the use by date specified on the package.Directions for use 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.H10: d4 (expiry date: 10/2023), g3 h11: h6 (method, result, conclusion) 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 preparation of a stent graft procedure in right renal artery, the stent graft was found inlayed in the middle of the balloon marker band and allegedly difficult to remove the protector.The stent moved with the protector and was separated from the balloon.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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16937873
• MDR Text Key: 315443447
• Report Number: 9616666-2023-00080
• 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
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: CMEY0106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• 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