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

Catalog Number EX061703C

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Thrombus (2101); No Consequences Or Impact To Patient (2199); Vascular System (Circulation), Impaired (2572)

Event Date 12/29/2016

Event Type  Injury  

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.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, product, or procedural details to bard.(b)(6).

Event Description

It was reported that the vascular stent fractured 2 weeks post placement.Reportedly, the stent was placed for treatment of an aso in the left low limb.The access was gained in the left brachial artery via anterograde puncture.An additional treatment was performed without success.The patient gets a drug therapy.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.No images documenting the alleged stent fracture were provided; therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre- or post- dilation as well as highly calcified vessels, the patient's condition or the vessel anatomy may result in an irregular stent placement and subsequent stent fracture.In this case, pre-dilation was performed and no issues occurred during tracking of the device to the lesion site, however, access was gained via the brachial artery and it is unknown whether post-dilation was performed.On the basis of the information available and as no image was provided, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct stent deployment procedure.Also the ifu addresses the potential risk of a stent fracture: "cases of fracture have been reported in clinical use of the lifestent 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." 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 three weeks post implantation of the vascular stent in the sfa via antegrade access through the left brachial artery for treatment of a pre-dilated (b)(4) stenosis (aso), the stent was found to be fractured.An additional treatment was performed without success.The patient received a drug therapy for further treatment.There was no reported patient injury.

• Brand Name: LIFESTENT XL VASCULAR STENT
• 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: 6516580
• MDR Text Key: 73538504
• Report Number: 9681442-2017-00151
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: EX061703C
• Device Lot Number: ANAT0728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR