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

Catalog Number EX062003JL

Device Problems Kinked (1339); Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The lot history records are being reviewed.The event is currently under investigation.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of the vascular stent for treatment of a pre-dilated lesion in the sfa via contralateral approach, the guide wire was withdrawn.During the attempt to re-insert the guide wire into the delivery system it got stuck.Finally, the delivery system and guide wire were removed as a single unit.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.The evaluation of the returned device confirmed that the guide wire got stuck after stent deployment.The delivery system was found to have been actively used and the stent was found to be released.A guide wire was found protruding from the proximal end of the grip.Four kinks were found at the proximal end of the sheath which may have been caused by the stuck guide wire, however, it is unknown when the kinking occurred.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be related to a difficult vessel anatomy leading to increased friction.In this case, pre-dilation of the lesion had been performed.Reportedly, the guide wire was running smoothly during insertion.Excessive release force may be another contributing factor to the reported event as this may lead to guide wire lumen deformation.The use of a 0.014" guide wire and the backloading of the guide wire (insertion into the grip-sided end of the system) also may contribute to the reported event.The reported event also may be use-related as rough handling of the device can lead to kinking or damage and subsequent friction increase.No damage to the device packaging was reported, and the guide wire lumen is being protected during the entire manufacturing process with a fully inserted mandrel.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 states: "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." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together." also the ifu states: "during stent deployment, use the 0.035" guide wire (recommended) for more support depending on vascular anatomy and/or lesion morphology." and "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.".

Event Description

It was reported that after successful deployment of the vascular stent for treatment of a pre-dilated lesion in the sfa via contralateral approach, the guide wire was withdrawn.During the attempt to re-insert the guide wire into the delivery system it got stuck.Finally, the delivery system and guide wire were removed as a single unit.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: 6471245
• MDR Text Key: 73344689
• Report Number: 9681442-2017-00131
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: EX062003JL
• Device Lot Number: ANAN2287
• 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: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• 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 Age: 70 YR
• Patient Weight: 70