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

Catalog Number FVM08040

Device Problems Break (1069); Difficult to Remove (1528); Self-Activation or Keying (1557); Misfire (2532)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.Based on the investigation of the returned catheter sample it could be confirmed that the user could only partially deploy the stent graft.The deployment mechanism was found in used condition, the stent graft was found partially deployed, and during evaluation testing a further deployment was impossible.The outer force transmitting catheter was found elongated which indicated that excessive release force must have been present during deployment attempt.An indication for a process related issue could not be found.Based on the information available, a definite root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one (1) malfunction.A review of the reported information indicated that model fvm12100 vascular stent graft allegedly experienced partial deployment and a difficult removal.This information was received from one source.This malfunction involved a patient with no known impact to the patient.The patient was a (b)(6) year old male weighing (b)(6) kgs.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.Based on the evaluation of the device sample returned a self-activation of the delivery system was confirmed, which led to the issue of blue pebax tip protruding from the outer sheath.This may have been misinterpreted by the customer as a missing blue tip due to a break.A break was not identified.A definite root cause for the issue identified could not be determined.Based on the information available, a definite root cause for the reported event could not be determined.The device is labeled for single use.H11: b5, d4, h6 (patient device).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 fvm08040 vascular stent graft allegedly experienced a break and self-activation.This information was received from a single source.There was no patient contact.The patient was a male, age and weight 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: 8809001
• MDR Text Key: 151643764
• Report Number: 9681442-2019-00130
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741145827
• UDI-Public: (01)00801741145827
• 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: 10/08/2019

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: FVM08040
• Device Lot Number: ANBS1645
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/08/2019
• Patient Sequence Number: 1