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

Catalog Number EX072003CL

Device Problems Failure to Advance (2524); Dent in Material (2526)

Patient Problem No Patient Involvement (2645)

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 patient or further procedural details.

Event Description

It was reported that during preparation, the delivery system could not be advanced over a 0.035"' guide wire.Another vascular stent was used with the same guide wire to complete the procedure successfully.There was no patient involvement.

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 condition of the returned sample confirmed that the guide wire could not be completely advanced through the delivery system.The stent was found to be loaded in the system and the delivery system had not been activated.An inner component of the system was found to be deformed resulting in resistance between the inner component and guide wire during tracking.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 transportation or storage of the device.The event also may be use-related as rough handling of the device during unpacking or guide wire insertion may lead to deformation.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used." and "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.".

• 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: 5519508
• MDR Text Key: 41313977
• Report Number: 9681442-2016-00086
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S048
• 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: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANYA0862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• 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