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

Catalog Number FVL14060

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for this malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation; however, a medical image 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 fvl14060 vascular stent graft allegedly experienced activation failure including expansion failures.This information was received from one source.This device was used on a patient with no patient consequences.The patient is a (b)(6) year old male with an unknown weight.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned; however a photo has been provided and reviewed.The investigation reported issue was confirmed for failure to expand.The definitive root cause is unknown.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: g1, h6 (method, 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 fvl14060 vascular stent graft allegedly experienced activation failure including expansion failures.This information was received from one source.This device was used on a patient with no patient consequences.The patient is a 61 year old male with an unknown weight.

• 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: 9955598
• MDR Text Key: 187527330
• Report Number: 9681442-2020-00104
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145346
• UDI-Public: (01)00801741145346
• 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: 06/30/2020

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: FVL14060
• Device Lot Number: ANDR2834
• Date Manufacturer Received: 06/25/2020
• Patient Sequence Number: 1