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

Catalog Number EX061003CS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  Injury  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.

Event Description

It was reported that after deployment in the popliteal artery, the length of the stent was measured to be 80 mm instead of 100 mm as indicated on the product label.An additional stent of 80 mm length was used to complete the procedure.Reportedly, the distal marker was hard to see under imaging prior to deployment of the stent in the popliteal artery.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.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned device, the reported stent foreshortening could not be confirmed.The stent was not returned as it remains in situ.The deployment modes were found to have been activated and functional.No deficiency which may have led to the reported failure was detected.No images of the implanted stent were provided to evaluate the reported foreshortening.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been 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 result in an irregular stent placement.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 supplied with this product sufficiently describes the correct application of the device.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." and "pre-dilation of the lesion should be performed using standard techniques.".

Event Description

It was reported that after deployment in the popliteal artery, the length of the stent was measured to be 80 mm instead of 100 mm as indicated on the product label.An additional stent of 80 mm length was used to complete the procedure.Reportedly, the distal marker was hard to see under imaging prior to deployment of the stent in the popliteal artery.There was no reported patient injury.

• Brand Name: LIFESTENT XL VASCULAR AND BILIARY STENT SYSTEM
• Type of Device: VASCULAR AND BILIARY STENT
• 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: 6508682
• MDR Text Key: 73309863
• Report Number: 9681442-2017-00146
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001272
• UDI-Public: (01)04049519001272(17)180923(10)ANAW3499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2018
• Device Catalogue Number: EX061003CS
• Device Lot Number: ANAW3499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2016
• 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: 65 YR
• Patient Weight: 90