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

Lot Number ANCR3339

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 this malfunction; therefore, a lot history review is currently being performed.The sample was returned to the manufacturer for inspection/evaluation.(b)(4).However, further evaluation of the device is pending.The company is still investigating the issue at this time.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.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl06120 vascular stent graft allegedly experienced misfire, positioning failure, fracture, and positioning problem.This information was received from one source.This event involved a patient with no patient consequences.The patient is a (b)(6) year old male weighing (b)(6) kgs.

Manufacturer Narrative

H10: the lot number was provided for this malfunction; therefore, a lot history review was performed.Device was returned for evaluation.Based on the information available, the reported issued was confirmed.A root cause has not been determined.The device was 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 indicated that model fvl06120 vascular stent graft allegedly experienced misfire, positioning failure, fracture, and positioning problem.This information was received from one source.This event involved a patient with no patient consequences.The patient is a 57 year old male weighing 62 kgs.

• 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: 9955718
• MDR Text Key: 187532184
• Report Number: 9681442-2020-00110
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144998
• UDI-Public: (01)00801741144998
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: ANCR3339
• Date Manufacturer Received: 06/19/2020
• Patient Sequence Number: 1