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

Catalog Number FVL06080

Device Problems Fracture (1260); Difficult to Remove (1528); Retraction Problem (1536); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported malfunction, the device was not returned to bd for evaluation, but a photo was provided for review.The company is still investigating the issue at this time.The device is labeled for single use.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced misfire, fracture, and retraction problem.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old male patient was (b)(6) kg.

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 images of the reported malfunction was received.Based on the images received, the investigation was confirmed for the sheath fracture but not confirmed for the partial deployment.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 endovascular stent graft products that are cleared in the us.The pro code for the fluency plus endovascular 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl06080 vascular stent graft allegedly experienced misfire, fracture, and difficult to remove.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 53 year old male patient was 65 kg.

• 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: 9957291
• MDR Text Key: 187718718
• Report Number: 9681442-2020-00115
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741144974
• UDI-Public: (01)00801741144974
• 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: 06/25/2020

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: FVL06080
• Device Lot Number: ANBR1722
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 06/25/2020
• Patient Sequence Number: 1