MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM

Catalog Number EX072502L

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Although this product is not sold in the u.S., this event is being reported under regulation 21 cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # p070014.

Event Description

It was reported that the vascular stent was found to be fractured during a follow-up examination 12 months post implantation in the femoral and popliteal artery.An additional treatment was not necessary.There was no reported patient injury.

Manufacturer Narrative

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 all specifications prior to shipment.No sample was returned.On the basis of the evaluation of the images provided, it could be confirmed that three stents have been placed overlapping and that the stent in the mid position was found fractured at the distal end close to the overlapping zone.The fracture was classified as complete circumferential fracture with preserved alignment of the components (type 3, stent fracture grading, michael jaff, michael dake et.Al.).Potential factors that could have led or contributed to the event reported have been evaluated.Previous investigations of similar complaints have been reviewed.An irregular stent placement may have led or contributed to a subsequent stent fracture.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, insufficient pre or post- dilation as well as highly calcified vessel, overlapping stent placement, patient condition or the vessel anatomy may have resulted in an irregular placement of the stent.Based on the information available a definite root cause for the event reported could not be determined.The ifu supplied with this device indicates that stent fracture is a potential adverse event that may occur.The ifu states: "cases of fracture have been reported in clinical use of the lifestent solo vascular stent.Cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced >10% elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture.The long-term clinical implications of these stent fractures have not yet been established." the ifu sufficiently describes the correct application of the device.Furthermore, the ifu states that pre-dilation of the lesion should be performed by using standard techniques and post stent expansion with a pta catheter is recommended.

Event Description

It was reported that the vascular stent was found to be fractured during a follow-up examination 12 months post implantation in the femoral and popliteal artery.An additional treatment was not necessary.There was no reported patient injury.

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.No sample was returned.On the basis of the evaluation of the images provided, it could be confirmed that three stents were placed in overlap and that the stent in the middle position was found to be fractured at the distal end close to the overlapping zone.The fracture was classified as a complete circumferential fracture with preserved alignment of the components (type 3, stent fracture grading acc.To (b)(6).Images taken post stent deployment demonstrate an elongation of the stent which leads to the conclusion that the stent fracture occurred as a consequence of the stent elongation during deployment.Potential factors that could have led or contributed to the event have been evaluated.Previous investigations of similar complaints have been reviewed.A stent elongation may occur as a consequence of an inadvertent movement of the hand or incorrect holding of the delivery system during stent release, insufficient pre- and/or post-dilation, highly calcified vessel's, overlapping stent placement, the patient's condition or the vessel anatomy.On the basis of the images provided, the stent was placed in overlapping technique at both ends.On the basis of the information available and the evaluation of the images, a definite root cause for the reported event could not be determined.The ifu indicates that stent fracture is a potential adverse event that may occur.The ifu states: "cases of fracture have been reported in clinical use of the lifestent solo vascular stent.Cases of stent fracture occurred in lesions that were moderate to severely calcified, proximal or distal to an area of stent overlap and in cases where stents experienced > 10 % elongation at deployment.Therefore, care should be taken when deploying the stent as manipulation of the delivery system may, in rare instances, lead to stent elongation and subsequent stent fracture.The long-term clinical implications of these stent fractures have not yet been established." the ifu sufficiently describes the correct application of the device.Furthermore, the ifu states that pre-dilation of the lesion should be performed by using standard techniques and post stent expansion with a pta catheter is recommended.

Event Description

It was reported that the vascular stent was found to be fractured during a follow-up examination 12 months post implantation in the femoral and popliteal artery.An additional treatment was not necessary.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5809449
• MDR Text Key: 50912468
• Report Number: 9681442-2016-00204
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: EX072502L
• Device Lot Number: ANZD1316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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
• Patient Weight: 80