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

Catalog Number EX062003CL

Device Problems Positioning Failure (1158); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  malfunction  

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.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample or image was provided.Therefore, the reported event could not be reproduced.Potential factors that could have contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The reported event may be related to a difficult vessel anatomy as highly tortuous or calcified vessels may lead to increased friction and subsequent release force increase.The event also may be use-related as rough handling of the device may lead to the event reported.The reported guide wire removal difficulties may have been caused by the reported deployment failure as excessive release force may lead to deformation of the guide wire lumen.Based on the information available and as no sample was returned, 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." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together." (b)(4).

Event Description

It was reported that during a stent placement procedure in the right sfa, the vascular stent could not be deployed.During retraction, the delivery system became stuck on the guide wire and had to be removed together with the guide wire as a single unit.A new guide wire and another stent were used to complete the procedure successfully.There was no reported patient injury.

Manufacturer Narrative

Due to a technical issue, the data in the following fields were not transmitted electronically in the previous submission.Not returned.

• 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: 4959919
• MDR Text Key: 23399169
• Report Number: 9681442-2015-00106
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2016
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANYL2886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2015
• 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: 73 YR
• Patient Weight: 66