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

Catalog Number LSM0800938

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stents that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stents are identified.No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiration date: (b)(6) 2017.The information provided by bard 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 bard.

Event Description

It was reported through the results of a clinical trial, that approximately three years post stent placement in the right common iliac artery, ultrasound demonstrated in-stent stenosis.Reportedly, there was no patient injury and no intervention was performed.

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stents that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stents are identified.Manufacturing review: a review of the device history records was performed.The lot met all test release criteria.Nothing was found to indicate a manufacturing related cause for this event.Investigation summary: the result of the investigation is inconclusive.The sample was not returned for evaluation.Based upon the available information a definitive root cause has not been determined.Labeling review: the instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Expiration date: 09/2017; manufacturing date: 10/2014.

Event Description

It was reported through the results of a clinical trial, that approximately three years post stent placement in the right common iliac artery, ultrasound demonstrated in-stent stenosis.Reportedly, there was no patient injury and no intervention was performed.

• 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
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7505386
• MDR Text Key: 108291424
• Report Number: 9616666-2018-00058
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081666
• UDI-Public: (01)05391522081666
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSM0800938
• Device Lot Number: 50114158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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