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

Catalog Number EX061501C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

As the lot number of the subject device has not been provided, a device history record review could not be performed.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 further product details.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr 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 post successful implantation of the vascular stent in the sfa via access through the common femoral artery for recanalization of the sfa and popliteal artery, the length of the stent was measured to be 100 mm instead of 150 mm.Reportedly, pre-dilation of the lesion had been performed with a 5 x 150 mm balloon.An additional stent was placed for completion of the procedure.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, the reported stent foreshortening could not be confirmed.Despite the poor resolution of the images, the stent strut pattern appeared to be homogeneous.Furthermore, adequate scaling information and documentation of the complete stent length was missing on the images.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have considered.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-dilation, highly calcified vessels, the patient's condition or the vessel anatomy may lead to an irregular stent placement.Reportedly, the tracking path was not tortuous but slightly calcified and the lesion had been pre-dilated.On the basis of the information available and the evaluation of the images, a definite root cause for the event reported could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.Also 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.Furthermore, the ifu states: "examine the stent and delivery system device for any damage if it is suspected that the sterility or performance of the device has been compromised, the device should not be used.".

Event Description

It was reported that post successful implantation of the vascular stent in the sfa via access through the common femoral artery for recanalization of the sfa and popliteal artery, the length of the stent was measured to be 110 mm instead of 150 mm.Reportedly, pre-dilation of the lesion had been performed with a 5 x 150 mmballoon.An additional stent was placed for completion of the procedure.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: 6157473
• MDR Text Key: 61852859
• Report Number: 9681442-2016-00324
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: EX061501C
• Device Lot Number: ANAP4062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• 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: 87 YR
• Patient Weight: 77