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

Model Number EX051003CS

Device Problems Fracture (1260); Premature Activation (1484); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

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 or procedural details to bard.

Event Description

It was reported that during a stenting procedure for treatment of a pre-dilated stenosis in the right middle sfa via access through the left femoral groin, the delivery system started to deploy the stent without removal of the shipping lock.Under fluoroscopy, it was observed that the tip of the delivery system was shredding.The device was removed and another stent of the same brand was used to complete the procedure 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.The evaluation of the returned device revealed that the deployment mechanism was in unused condition with the stent being partially and prematurely deployed.In addition, it can be confirmed that the distal end of the stent was fractured which is considered a consequence of the premature stent deployment.The disposition of the distal stent end is unknown.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The premature stent deployment may be related to friction increase between guide wire and guide wire lumen or between the outer surface of the delivery system and the vessel.During evaluation, a friction issue between guide wire lumen and guide wire could not be identified.A difficult vessel anatomy may lead to increased friction, however, in this case the tracking path was not tortuous or calcified and the lesion had been pre-dilated.Rough handling of the device during shipping, storage or preparation also may lead to friction increase and may be a contributing factor to the reported event.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: "visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed." and "if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.".

Event Description

It was reported that during a stenting procedure for treatment of a pre-dilated stenosis in the right middle sfa via access through the left femoral groin, the delivery system started to deploy the stent without removal of the shipping lock.Under fluoroscopy, it was observed that the tip of the delivery system was shredding.The device was removed and another stent of the same brand was used to complete the procedure successfully.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; 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: 6489295
• MDR Text Key: 72661628
• Report Number: 9681442-2017-00139
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007922
• UDI-Public: (01)04049519007922(17)170828(10)ANZH2675
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: EX051003CS
• Device Catalogue Number: EX051003CS
• Device Lot Number: ANZH2675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2015
• 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: 78 YR