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

Catalog Number FVL14100

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The company is still investigating the issue at this time.The catalog number identified has not been cleared in the u.S.But, it 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 are identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl14100 vascular stent graft allegedly experienced partial deployment.This information was received from one source.The one reported malfunction involved one patient with no consequences.The patient was reported to be a male weighing (b)(6) kgs who's age was not provided.

Manufacturer Narrative

H10: the lot number for the device was provided, therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation of the reported partial deployment and positioning failure was confirmed.A definite root cause for the reported issues could not be determined.The device is labeled for single use.H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it 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 are identified in d2.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 fvl14100 vascular stent graft allegedly experienced partial deployment and positioning failure.This information was received from one source.The one reported malfunction involved one patient with no consequences.The patient was reported to be a male weighing 63 kgs who's age was 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: 10763431
• MDR Text Key: 219529982
• Report Number: 9681442-2020-00241
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145360
• UDI-Public: (01)00801741145360
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL14100
• Device Lot Number: ANDZ3715
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1