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

Catalog Number FVL08100

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The report summarizes one malfunction.A review of the reported information indicated that model, fvl08100, vascular stent graft, allegedly failed to expand and ruptured upon removal.This information was received from a single source.This malfunction involved a (b)(6) year old male weighing (b)(6) kgs with no consequences.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9188963
• MDR Text Key: 169243487
• Report Number: 9681442-2019-00175
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145124
• UDI-Public: (01)00801741145124
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL08100
• Device Lot Number: ANDP3854
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1