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

Catalog Number LSM1351238

Device Problems Structural Problem (2506); Material Deformation (2976)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/22/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.(expiry date 12/2019).

Event Description

It was reported that the balloon expandable vascular covered stent allegedly collapsed, therefore causing an obstruction.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: the investigation is confirmed for the reported stent collapsed issue reported.The stent was returned with extensive damage.It appeared to have been originally expanded to its nominal diameter.One side was flattened and compressed for a length of 12mm.The other expanded side was also damaged and deformed.The type of damage exhibited would indicate that handling techniques may have contributed to the reported event.The definitive root cause for the reported issue could not be determined based upon available information.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.Labeling review: the ifu for the lifestream product was reviewed for information relevant to the reported event: warnings: ¿ do not use if packaging/pouch is damaged.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.¿ prior to device use, refer to the covered stent sizing table on the label and read the instructions for use.Potential adverse events ¿ covered stent deformation (expiry date 12/2019).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 the balloon expandable vascular covered stent allegedly collapsed, therefore causing an obstruction.There was no reported patient injury.

• Brand Name: LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8253931
• MDR Text Key: 133322439
• Report Number: 9616666-2018-00191
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081765
• UDI-Public: (01)05391522081765
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM1351238
• Device Lot Number: CMBN0296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1