MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY VASCULAR STENT GRAFT

Catalog Number FVM06080

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will 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.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 that during placement of a t-branch graft, tracking of the stent graft delivery system to the target lesion was allegedly difficult.It was further reported that the indication was an emergency treatment of the patient.Reportedly, the procedure was concluded without placement of the stent grafts and rescheduled approximately one week later.During the follow up procedure, stent grafts were placed in two renal vessels without incident.There was no reported patient injury.

• Brand Name: FLUENCY VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7551478
• MDR Text Key: 109505307
• Report Number: 9681442-2018-00068
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145490
• UDI-Public: (01)00801741145490
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FVM06080
• Device Lot Number: ANAX1647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• 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