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

Catalog Number LSM0801238

Device Problem Material Deformation (2976)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/14/2021

Event Type  Injury  

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: 02/2023).

Event Description

It was reported that during a procedure, the distal part of the balloon was allegedly flared a small part of the proximal side of the stent that was outside the sheath.It was further reported that an open procedure was done by a surgeon to remove the sheath and the stent.The patient status was unknown.

Event Description

It was reported that during a procedure, the distal part of the balloon was allegedly flared a small part of the proximal side of the stent that was outside the sheath.It was further reported that an open procedure was done by a surgeon to remove the sheath and the stent.The patient status was unknown.

Manufacturer Narrative

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 to the manufacturer for evaluation.The result of the investigation is confirmed for the reported material deformation issue.One end of the returned stent was slightly flared outwards and the stent frame was slightly damaged.The lifestream catheter was not returned.A 45cm sheath and guidewire 0.035" lodged within from unknown manufacturer was also returned.A possible contributor for the stent damage was healthcare professional handling as it was reported that an open procedure was done by a surgeon to remove the sheath and the stent.The root cause for the reported material deformation issue could not be determined based upon the available information received from the field communications.Labeling review: the instruction 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.¿ should excessive resistance be felt at any time during the insertion process, do not force passage.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.¿ anatomical variances may complicate the procedure; use caution when advancing the endovascular system through tortuous or difficult anatomy directions for use: site access and preparation 1.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.2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length 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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.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: d4 (expiry date: 02/2023), 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.See h10.

• 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: 12292377
• MDR Text Key: 265556258
• Report Number: 9616666-2021-00122
• 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
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0801238
• Device Lot Number: CMEQ0404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention