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

Catalog Number EX072003CL

Device Problems Positioning Failure (1158); Kinked (1339); Difficult to Remove (1528); Sticking (1597); Out-Of-Box Failure (2311); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

It was reported that the delivery system was found to be kinked after removal from the packaging.Therefore, the device was not used.Another stent was implanted to complete the procedure.Upon sample receipt, a guide wire was found to be stuck in the delivery system and the vascular stent was partially deployed.

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The info provided by bard represents all of the known info at this time.As the subject device was not used in or on a pt, on pt details were provided.

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 breakage of a force transmitting component when the stent was being partially released.Increased friction is considered the reason for the increased release force and subsequent component breakage.The sheath of the delivery system was found to be kinked potential factors that could have led or contributed to the event have been considered.Previous investigations of similar complaints have been reviewed.The kink of the sheath may have been caused by shipping, storage or rough handling of the device during unpacking.The deployment failure may be related to a difficult anatomy as highly tortuous or calcified vessels may lead to increased friction and subsequent release force increase.Also insufficient flushing of the device may be a contributing factor.In this case, no procedural details were provided.Based on the information available, a definite root cause could not be determined.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4804558
• MDR Text Key: 5829971
• Report Number: 9681442-2015-00054
• Device Sequence Number: 1
• Product Code: NIP
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2016
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANYG3489
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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