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

Catalog Number	EX061003CS
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history records are being reviewed.The event is currently under investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 6508682
• Report Number: 9681442-2017-00146
• Device Sequence Number: 16460798
• Product Code: NIP
• UDI-Device Identifier: 04049519001272
• UDI-Public: (01)04049519001272(17)180923(10)ANAW3499
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 90