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

Catalog Number FVL10100

Device Problems Positioning Failure (1158); Fracture (1260); Difficult to Remove (1528); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device for the malfunction has not been returned to the manufacturer for evaluation; however two images of the reported malfunction was received.The investigation of the reported malfunction is currently underway.The devices are labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl10100 vascular stent graft allegedly experienced positioning failure, fracture, and difficulty to remove.This information was received from a single source.The malfunction involved a patient with no reported consequences.The patient was reported as a (b)(6) year-old male whose weight was not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl10100 vascular stent graft allegedly experienced positioning failure, fracture, and difficulty to remove.This information was received from a single source.The malfunction involved a patient with no reported consequences.The patient was reported as a 78-year-old male whose weight was not provided.

Manufacturer Narrative

H10: the lot no for the device was provided, therefore a lot history review was performed.The device has not been returned to the manufacturer for evaluation; however two images of the reported malfunction was received.Based on the images received,the investigation is confirmed for partial deployment of stent graft.A definite root cause for the reported malfunction 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 us, but is similar to the fluency plus vascular stent graft products that are cleared in the us.The pro code for the fluency plus vascular stent graft products is 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.

• 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: 9955641
• MDR Text Key: 187529171
• Report Number: 9681442-2020-00106
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145247
• UDI-Public: (01)00801741145247
• 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 Catalogue Number: FVL10100
• Device Lot Number: ANDW1386
• Date Manufacturer Received: 06/19/2020
• Patient Sequence Number: 1