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

Catalog Number EX072003CL

Device Problems Positioning Failure (1158); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

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 procedural details.

Event Description

It was reported that the vascular stent could not be deployed during the stent placement procedure.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 sample confirmed the reported failure to deploy the stent due to the breakage of a force transmitting component.The condition of the returned device indicates the presence of high release force.Increased friction is considered the reason for increased release force and subsequent deployment failure.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The event may be related to a difficult anatomy as highly tortuous or calcified vessels may lead to increased friction and subsequent release force increase.In this case, no procedural or anatomical details were provided.The reported event also may also be use-related as rough handling of the device may lead to deformation and subsequent friction increase.Based on the information available, a definite root cause for the reported event could not be determined.The ifu states: "do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit" and "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.".

• 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: 5009723
• MDR Text Key: 24544415
• Report Number: 9681442-2015-00128
• 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
• Reporter Occupation: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANYH0086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2014
• 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