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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

As the lot number of the subject device has not been provided, a device history record review could not be performed.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.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 patient or further procedural details.

Event Description

It was reported that post implantation of the vascular stent, the stent was found to be foreshortened.There was no reported patient injury.

Manufacturer Narrative

As the lot number of the subject device was not provided, a device history record review could not be performed.No sample was returned.An image was provided showing a stent implanted inside a vessel.An adequate length measurement was not possible due to missing scaling information.A strut structure evaluation for stent foreshortening was not possible because the single struts were not visible.Therefore, the reported stent foreshortening could not be reproduced.Potential contributing factors which may have caused or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.Stent foreshortening during deployment may be caused by a distal movement of the stent when the distal stent end is already being released and anchored.A distal stent movement during deployment may be caused by increased friction in the distal catheter section between outer catheter and vessel wall or introducer sheath if the grip is not sufficiently fixed, or if the system is not held in a straight configuration.Under these circumstances, the relative movement initiated by the grip may lead to distal movement of the inner catheter instead of a proximal movement of the outer sheath.Fracture increasing conditions such as insufficient pre-dilatation, highly calcified vessels, the patient's condition or the vessel anatomy may be contributing factors.An inadvertent movement of the hand during stent release may be another contributing factor to the reported event.In this case, the system was held slack free in a straight line and the silver stent sheath had not been not touched during deployment.It is unknown whether the lesion had been pre-dilated.On the basis of the information available and the images, a definite root cause for the event reported could not be determined.The ifu supplied with this device sufficiently describes the correct stent placement procedure.Also the ifu states: "remove slack from the delivery system catheter held outside the patient (.).Any slack in the delivery system catheter (outside the patient) could result in deploying the stent beyond the target site." and "pre-dilation of the lesion should be performed using standard techniques." (b)(4).

Event Description

It was reported that post implantation of the vascular stent, the stent was found to be foreshortened.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: VASCULAR 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: 6412520
• MDR Text Key: 70179527
• Report Number: 9681442-2017-00110
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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