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

Catalog Number EX061203CS

Device Problems Difficult to Remove (1528); Sticking (1597); Material Torqued (2980); Material Twisted/Bent (2981)

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

Event Date 05/11/2015

Event Type  Injury  

Event Description

It was reported that the vascular stent was found to be twisted upon deployment in the sfa.The delivery system got stuck during retraction but could be fully removed finally.Angiography showed tht the vascular stent was accordioned.Therefore, post-dilation with a balloon was performed.The final image showed good flow through the stent.No patient 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.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 and no images were returned.Therefore, the reported stent twisting could not be confirmed potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The twisting of this kind of stent may be caused by interactions of various use-related and anatomical factors with the given stent design.Also, various physical forces including individual patient factors may contribute to the twisting of a stent in this region.In this case, the vessel was calcified.On the basis of the information available and as no images were provided, a definite root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct deployment of the stent.Also the ifu states that the use of appropriate accessories (sf or larger introducer sheath, 0035 diameter guide wire) is required.

• Brand Name: LIFESTENT 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: 4833538
• MDR Text Key: 5908287
• Report Number: 9681442-2015-00061
• 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: 05/11/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2016
• Device Catalogue Number: EX061203CS
• Device Lot Number: ANYG4067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 06/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention