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

Catalog Number FVL12040

Device Problems Premature Activation (1484); Failure to Advance (2524); Misfire (2532); Device Damaged by Another Device (2915)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The product 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.

Event Description

It was reported that prior to a stent graft deployment procedure in the brachiocephalic vein through the right av fistula, the outer catheter of the stent graft delivery system was allegedly found penetrated by the guidewire upon loading, outside of the patient's body.The health care provider removed the whole system and used another device to complete the procedure.There was no reported patient contact.

Manufacturer Narrative

A manufacturing review was performed.The lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.No additional complaint has been reported for this lot number previously.On the basis of the returned stent graft delivery system the alleged penetration of the outer catheter with a guide wire could not be confirmed as the outer catheter was in good condition and no damages could be identified.The stent graft was found to be premature deployed; even though the safety clip was in place upon sample receipt.The delivery system was not obviously contaminated.As reported, the device was not used on patient.As the reported penetration of the outer sheath of the delivery system could not be confirmed the reported issue could not be reproduced.Therefore, the investigation will be closed with inconclusive result.A definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding preparation of the device the ifu states that "prior to loading the vascular system over a guide wire, both ports must be flushed with sterile saline.Flushing these lumens will also facilitate stent graft deployment." regarding the usage of accessories the ifu states: "a super stiff guide wire (0.035 in.) is advanced from a femoral artery puncture site." the reported application represents an off label use of the device.The fluency plus vascular stent graft system is intended for use in the iliac and femoral arteries.(b)(4).

Event Description

It was reported that prior to a stent graft deployment procedure in the brachiocephalic vein through the right av fistula, the outer catheter of the stent graft delivery system was allegedly found penetrated by the guidewire upon loading, outside of the patient's body.The health care provider removed the whole system and used another device to complete the procedure.There was no patient contact.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6952386
• MDR Text Key: 90555117
• Report Number: 9681442-2017-00282
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: FVL12040
• Device Lot Number: ANBP2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR