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

Catalog Number EX070203CS

Device Problems Premature Activation (1484); Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.

Event Description

It was reported that during the stent placement procedure in the sfa, the delivery system got stuck in the valve of a 7 f introducer sheath.During removal of the delivery system, reportedly the vascular stent came out of the delivery system.Another stent was used to complete the procedure successfully.No patient injury was reported.

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 the premature stent release and that the deployment mechanism had not been used.Potential factors which may have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.This type of event may be related to the usage of inappropriate accessories or insufficient flushing of the device.The premature stent release may have caused the reported impossibility to pass the delivery system through the introducer sheath.Premature stent deployment may be associated with rough handling of the device during shipping, storage or preparation.On the basis of the information available, 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 "flush the inner lumen of the device with saline prior to use." and "if resistance is met during delivery system introduction, the system should be removed and another system should be used." furthermore, the ifu recommends the use of a 0.035 inch guide wire and states: "gain femoral access at the appropriate site using a 6 f (2.0 mm) or larger introducer sheath.".

• Brand Name: LIFESTENT 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: 5217176
• MDR Text Key: 31214433
• Report Number: 9681442-2015-00211
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001227
• UDI-Public: (01)04049519001227(17)170813(10)ANZH1319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S047
• 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: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2017
• Device Catalogue Number: EX070203CS
• Device Lot Number: ANZH1319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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: 76 YR
• Patient Weight: 95