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

Catalog Number FVL10100

Device Problems Positioning Failure (1158); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the two malfunctions; therefore, a lot history review is currently being performed.Out of the reported two malfunctions, two devices were returned to the manufacturer for evaluation.One malfunction was confirmed for misfire.The definitive root cause is unknown.For the remaining returned device, the company is still investigating the issue at this time.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 two malfunctions.A review of the reported information indicated that model fvl10100 vascular stent graft allegedly experienced positioning failure and misfire.This information was received from various sources.Of the two events, both involved patients with no patient consequences.One patient was a (b)(6) year old, (b)(6) kg male.Age, weight, and gender was not provided for the second patient.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model fvl10100 vascular stent graft allegedly experienced positioning failure and misfire.This information was received from various sources.Of the two malfunctions, both involved patients with no patient consequences.One patient was a 78 years old, 70 kg male.Age, weight, and gender was not provided for the second patient.

Manufacturer Narrative

H10: of the two devices, two lot numbers were provided, and lot history reviews were performed.Out of the reported two malfunctions, two devices were returned for evaluation.Misfire was confirmed for two devices.A definitive root cause could not be determined.The devices are 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: 9955646
• MDR Text Key: 187528252
• Report Number: 9681442-2020-00105
• 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: 06/26/2020

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: ANCZ2838
• Date Manufacturer Received: 06/19/2020
• Patient Sequence Number: 1