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

Catalog Number EX062003CL

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2015

Event Type  Injury  

Event Description

It was reported that during placement of the vascular stent in the sfa, the stent could not be deployed any further after being partially released.During the attempt to complete the deployment manually.A part of the stent broke off and remained in the pt.The delivery system with the undeployed part of the stent could be retracted without issue.Another stent was implanted inside the remaining portion of the fractured stent to fix it against the vessel wall.No pt injury was reported.

Manufacturer Narrative

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

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 partial release and fracture of the stent.Increased friction is considered the reason for increased release force and subsequent deployment failure.The image provided confirmed that the fractured part of the stent was covered with an additional stent.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to difficult anatomical conditions as tortuous or calcified vessels may lead to increased friction.The use of a guide wire smaller than recommended in the ifu (0.014 inch instead of 0.035 inch) also may be a contributing factor.The event also may be use-related as rough handling of the device can lead to friction increase.Based on the information available, a definite root cause 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." furthermore, the ifu recommends the use of a 0.035 inch guide wire.

• 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: 4794673
• MDR Text Key: 16179177
• Report Number: 9681442-2015-00048
• 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
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANYJ3361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/30/2015
• Initial Date FDA Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR