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

Catalog Number FVM08120

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.The sample was not returned for evaluation, however a photo was provided for review.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of reported information indicates that model fvm08120, vascular stent graft, allegedly experienced fracture and difficult or delayed positioning.This information was "recieved" from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

For the reported event the lot number was provided and a lot history review was performed.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.The sample was not returned for evaluation, however a photo review was performed.Fracture of the outer sheath was confirmed for the device.A root cause has not been determined.The device was labeled for single use.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 reported information indicates that model fvm08120, vascular stent graft, allegedly experienced fracture and difficult or delayed positioning.This information was recieved from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, 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: 9955502
• MDR Text Key: 187521363
• Report Number: 9681442-2020-00096
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145650
• UDI-Public: (01)00801741145650
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVM08120
• Device Lot Number: ANDS4388
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 06/24/2020
• Patient Sequence Number: 1