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

Model Number FEM08040

Device Problems Positioning Failure (1158); Material Invagination (1336); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

The lot history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient or procedural details to bard.

Event Description

It was reported that during a sheathless stenting procedure of the cephalic arch via access through the cephalic vein, the delivery system could not be advanced to the lesion site due to an alleged damage of the distal tip of the delivery system.The device was retracted without difficulties.Another stent graft was used and failed with the same issue.After the failure to insert the second delivery system into the patient, the procedure was called off because no more devices were available to continue the procedure.There was no reported patient injury.This is the same patient as reported in medwatch report with patient id # (b)(6).

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.The evaluation of the returned device revealed that the distal tip of the delivery system was invaginated.The invagination of the tip section matches the deformation reported by the customer.During the performed patency test, a device compatible 0.035" guide wire could be advanced through the delivery system without issue.On the basis of the information provided and the condition of the returned device, a post procedural attempt was made by the customer to deploy the stent graft which failed due to the invagination of the tip section.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The invagination of the tip section may be caused by rough handling of the delivery system during unpacking or preparation.As reported, a damage to the tip was identified after unpacking of the device.The invagination of the distal tip also may have been caused by the reported insertion issues of the device into the patient.Not using an introducer sheath may be another contributing factor to the reported insertion difficulties finally leading to the tip deformation.In this case, no introducer sheath was used for device insertion.The usage of an inappropriately sized guide wire also may cause advancement issues.As reported, a 0.035'' guide wire was used in this case.In addition, it was reported that the device was only flushed through the distal port which would, however, affect the advancement performance of device and guide wire but in this case, no guide wire advancement issues were reported.Additionally, during sample evaluation a deployment issue was identified.The information provided and the condition of the returned device leads to the conclusion that the stent graft was attempted to be deployed after the procedure which was impossible due to the invaginated tip.On the basis of the information available and the evaluation of the returned device, a definite root cause for the reported event could not be determined.The ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed." in addition, the ifu states that prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline.Furthermore, the ifu indicates that a 0.035" (0.89 mm) guide wire and an introducer sheath of appropriate inner diameter are required for the procedure.(b)(4).

Event Description

It was reported that during a sheathless stenting procedure of the cephalic arch via access through the cephalic vein, the delivery system could not be advanced to the lesion site due to an alleged damage of the distal tip of the delivery system.The device was retracted without difficulties.Another stent graft was used and failed with the same issue.After the failure to insert the second delivery system into the patient, the procedure was called off because no more devices were available to continue the procedure.There was no reported patient injury.This is the same patient as reported in medwatch report with patient id # (b)(6).

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstr. 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6566999
• MDR Text Key: 75186759
• Report Number: 9681442-2017-00180
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008486
• UDI-Public: (01)04049519008486(17)200203(10)ANBP0256
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

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: Health Professional
• Device Expiration Date: 02/03/2020
• Device Model Number: FEM08040
• Device Catalogue Number: FEM08040
• Device Lot Number: ANBP0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2017
• Initial Date FDA Received: 05/15/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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: 66 YR