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

Catalog Number FVL05100

Device Problems Device Markings/Labelling Problem (2911); Adverse Event Without Identified Device or Use Problem (2993); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer; however photos were provided and a photo review will be performed.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 to date.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The 510 k number and pro code for the fluency plus vascular stent graft products are identified.Accordingly, this event has been determined to be mdr reportable.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 there is an alleged labeling issue.Reportedly, the manufacturer label and the supplemental label differ on the expiration date.There was no patient involvement.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not performed.Investigation results determined that there was no labeling issue identified, but instead was a device markings issue.However, since an initial had already been submitted to the fda, this supplemental mdr is being submitted reporting the event as not reportable.Investigation summary: based on the evaluation of the images provided it could be confirmed that the supplemental label that was attached to the product after shipment did not match the information on the manufacturing label.The product expiration date on the supplemental label was one month later.The manufacturing label was found to be correct, and matching the manufacturing software system information.The found issue was not related to the angiomed production process.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The 'use by' symbol including the use by date clearly indicates the product expiration date.In this case the angiomed expiry date was correctly printed and the product was not used after expiration date.

Event Description

It was reported that there was an alleged labeling issue.Reportedly, the manufacturer label and the supplemental label differ on the expiration date.There was no patient involvement.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7311478
• MDR Text Key: 101484609
• Report Number: 9681442-2018-00029
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144912
• UDI-Public: (01)00801741144912
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/28/2018
• Device Catalogue Number: FVL05100
• Device Lot Number: ANZA2369
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1