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

Catalog Number EX060801JL

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.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 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 after successful deployment of the vascular stent for treatment of a stenosis in the right middle sfa via access through the left cfa, the 0.035" guide wire used during the procedure was removed and the physician tried to insert a 0.014" guide wire into the delivery system for post-dilation.However, the 0.014" guide wire became stuck and fractured at the joint of the handle.The guide wire was removed and another 0.014" guide wire was used to perform the post-dilation successfully.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.During the evaluation of the returned device, a stuck guide wire could not be confirmed.As reported, the stent could be deployed successfully.During evaluation, it was not possible to insert a guide wire due to a kink in the system.It is unknown, when and where the kink occurred.No guide wire was returned and no guide wire fragments were found.For this reason, 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.As reported, the event occurred after successful stent deployment.This kind of event may be related to a difficult vessel anatomy or rough handling of the device which both can lead to increased strain in the catheter section.Also the insertion of the guide wire from the proximal (grip) side may be a contributing factor to the reported event.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.The ifu states: "gain femoral access utilizing a 6 f (2 mm) or larger introducer sheath." and "pre-dilation of the lesion should be performed using standard techniques." also the ifu states: "advance the stent system over the guide wire through the sheath introducer." and "position the tip of the stent system past the target site." furthermore, the ifu indicates: "guide wire cannot be inserted from the luer port of the delivery system.Do not attempt to exchange the guide wire after insertion of catheter." and "keep the device as straight as possible following removal from the packaging and while inserted in the patient.Failure to do so may impede the optimal deployment of the implant." in addition, the ifu states: "if resistance is met while retracting the delivery system over a guidewire remove the delivery system and guidewire together." updated 'eval code & desc - conclusion1' due to completion of evaluation.

Event Description

It was reported that after successfull deployment of the vascular stent for treatment of a stenosis in the right middle sfa via access through the left cfa, the 0.035" guide wire used during the procedure was removed and the physician tried to insert a 0.014" guide wire into the delivery system for post-dilation.However, the 0.014" guide wire became stuck and fractured at the joint of the handle.The guide wire was removed and another 0.014" guide wire was used to perform the post-dilation successfully.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• 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: 6135272
• MDR Text Key: 61148464
• Report Number: 9681442-2016-00314
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/04/2016

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
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: EX060801JL
• Device Lot Number: ANAT0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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