MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG FLUENCY PLUS ENDOVASCULAR SENT GRAFT

Catalog Number FEM12060

Device Problem Partial Blockage (1065)

Patient Problem Reocclusion (1985)

Event Date 01/28/2015

Event Type  Injury  

Event Description

It was reported that the stent graft which was implanted in (b)(6) 2014 in the right subclavian artery was found to be blocked.Then a bare stent was deployed, overlapping and extending the stented area proximally.No pt injury was reported.This is the same pt as reported in medwatch report # 961442-2015-00013 and 961442-2015-00014.

Manufacturer Narrative

The lot number has been provided.The device history records are being reviewed.The investigation is currently underway.

• Brand Name: FLUENCY PLUS ENDOVASCULAR SENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4567341
• MDR Text Key: 20460513
• Report Number: 9681442-2015-00015
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2017
• Device Catalogue Number: FEM12060
• Device Lot Number: ANYE2488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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): Required Intervention