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

Catalog Number FVL12080

Device Problems Break (1069); Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided, and a lot history review will be performed.The sample and an electronic photo will be returned to the manufacturer for inspection/evaluation.The company is still investigating the issue at this time.The device is labeled for single use.The catalog number has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model fvl12080 vascular stent graft allegedly experienced stuck causing, and detachment.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the device was provided and a lot history review will be performed.The sample and an electronic photo will be returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported catheter break and inconclusive for other issues.Based upon the available information, the definitive root cause for this event 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.H10: g4, h6 (device code: 1528(difficult to remove)) h11: b5, h6 (device, 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 fvl12080 vascular stent graft allegedly experienced device-device incompatibility, failure to advance, difficult to remove and break.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender of the patient were not provided.

• 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: 10738254
• MDR Text Key: 213186224
• Report Number: 9681442-2020-00232
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145292
• UDI-Public: (01)00801741145292
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FVL12080
• Device Lot Number: ANDQ1746
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1