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

Catalog Number UNKNOWN LIFESTREAM US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Embolism (1829); Injury (2348)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.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.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: laird, j.R., zeller, t., holden, a., scheinert, d., moore, e., mendes, r., ¿ schulte, k.-l.(2019).Balloon-expandable vascular covered stent in the treatment of iliac artery occlusive disease: 9-month results from the bolster multicenter study.Journal of vascular and interventional radiology, 30(6).Doi: 10.1016/j.Jvir.2018.12.031.

Event Description

It was reported in an article from the journal of vascular interventional radiology titled " balloon-expandable vascular covered stent in the treatment of iliac artery occlusive disease: 9-month results from the bolster multicenter study " that total of 230 covered stent grafts were placed in 155 patients for iliac artery occlusive disease.One patient experienced a posterior tibial artery embolism during the treatment procedure, which was resolved with a heparin infusion.One patient had major amputation and six patients underwent target lesion revascularization (tlr).The status of the patients was not provided.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR STENT GRAFT
• 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: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9282607
• MDR Text Key: 179519125
• Report Number: 9616666-2019-00141
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN LIFESTREAM US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/09/2019
• 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
• Patient Outcome(s): Other; Required Intervention