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

Catalog Number FVL14080

Device Problems Material Perforation (2205); Misfire (2532); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation identified perforation of the tip and partial deployment; however, the evaluation did no identify failure to expand.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl14080 vascular stent graft allegedly experienced material perforation, partial deployment, and failure to expand.This information was received from a single source.The malfunction involved a patient with no consequence.The patient was reported as a (b)(6)-year-old male weighing (b)(6) kgs.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The device has been returned to bd for evaluation.The evaluation confirmed for perforation of the tip, partial deployment, for material deformation, and failure to expand.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: b5; g4, h6 (2976-material deformation).H11: d1; h6 (results, conclusion).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 fvl14080 vascular stent graft allegedly experienced material perforation, partial deployment, material deformation, and failure to expand.This information was received from a single source.The malfunction involved a patient with no consequence.The patient was reported as a 78-year-old male weighing 90 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: 8795341
• MDR Text Key: 151285383
• Report Number: 9681442-2019-00106
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145353
• UDI-Public: (01)00801741145353
• 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: 10/07/2019

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: FVL14080
• Device Lot Number: ANCT0347
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/07/2019
• Patient Sequence Number: 1