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

Catalog Number LSM0800737

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 12/2022).The catalog number identified has not been cleared in the us but is similar to the lifestream product that are cleared in the us.The pro code and 510k number for the lifestream product is identified.

Event Description

It was reported that during preparation of stent graft deployment procedure in femoral artery, the stent graft was allegedly defective.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that during preparation of stent graft deployment procedure in femoral artery, the stent graft was allegedly defective.The procedure was completed 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 product that are cleared in the us.The pro code and 510k number for the lifestream product is identified in d2 and g5.H10: manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation results: the sample was returned for evaluation.The investigation is confirmed for the reported device damaged prior to use issue.There was damage noted on one side of the stent.The stent was returned separate to the device and lodged within the stent guard.There was a yellow bodily substance residue noted on the stent.This is evidence that the stent had been handled by the health care provider.The definitive root cause for the reported device damage prior to use issue could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 12/2022).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.

• 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: 10566433
• MDR Text Key: 207918685
• Report Number: 9616666-2020-00083
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081529
• UDI-Public: (01)05391522081529
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0800737
• Device Lot Number: CMEN0191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1