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

Catalog Number FVM09100

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 product classification code for the fluency plus endovascular stent graft product is identified.The lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has been returned to the manufacturer for evaluation.The investigation of the reported malfunction is currently underway.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvm091100 vascular stent graft allegedly experienced break, detachment of device or device component, difficult or delayed positioning and fracture.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvm091100 vascular stent graft allegedly experienced break, detachment of device or device component, difficult or delayed positioning and fracture.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

Manufacturer Narrative

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 product classification code for the fluency plus endovascular stent graft product is identified.The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction was returned to the manufacturer for evaluation.The investigation is confirmed for fracture, however break and detachment could not be identified.A definite root cause for the reported issue could not be determined.The device is 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.

• Brand Name: FLUENCY PLUS VASCULAR STENT GRAFT
• Type of Device: VASULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9955645
• MDR Text Key: 187529624
• Report Number: 9681442-2020-00107
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145704
• UDI-Public: (01)00801741145704
• 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: 06/29/2020

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: FVM09100
• Device Lot Number: ANCR0785
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 06/29/2020
• Patient Sequence Number: 1