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

Catalog Number FVM10120

Device Problems Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was returned to manufacturer for inspection/evaluation, however image was provided for review.The company is still investigating the issue at this time.The device is labeled for single use.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 pro code for the fluency plus endovascular stent graft products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model fvm10120 vascular sent graft allegedly fractured and partial deployment.The information was received from a single source.This malfunction involved one patient with no patient consequences.Patients' sex, age and gender were not provided.

Manufacturer Narrative

H10: the catalog number identified in section d4 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 pro code for the fluency plus endovascular stent graft products is identified in d2.H10: the lot number for the device was provided and a lot history review will be performed.The device was returned to manufacturer for inspection/evaluation; however, three photo were provided for review.The evaluation is identified for fracture and partial deployment.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd 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 bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model fvm10120 vascular sent graft allegedly experienced fracture, misfire and positioning failure.The information was received from a single source.This malfunction involved one patient with no patient consequences.Patients' sex, age and gender were not provided.

• 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: 10748279
• MDR Text Key: 213457142
• Report Number: 9681442-2020-00234
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145773
• UDI-Public: (01)00801741145773
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVM10120
• Device Lot Number: ANCQ3737
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1