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

Catalog Number VIES10060

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot 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 to bard.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # p080007.

Event Description

It was reported that post successful stent implantation, the vascular stent seemed to be longer than labeled.The stent remains implanted.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.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 for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.During the manufacturing process of this product, a quality control step to inspect the length of the stent of each device is being performed.In addition, prior to the stent loading process a stent identification control takes place.Based on the review of the manufacturing records, the subject device was manufactured according to the specifications.No deviations were found.On the basis of the information available and as no sample or image was returned for evaluation, a definitive root cause for the reported complaint could not be determined.The ifu supplied with this device sufficiently describes the correct stent deployment procedure.Also the ifu states: "the stent experiences length changes less than 10 % during deployment if appropriate oversizing is used".Furthermore, the ifu states: "use the following guidelines for proper stent diameter selection: for target lumens ranging from 5 mm to 9 mm, select a stent with an unconstrained diameter of 1 mm larger than the target lumen.For target lumens ranging from 10 mm to 13 mm, select a stent with an unconstrained diameter of 1 to 2 mm larger than the target lumen." and "center the proximal stent markers and both overlapping distal markers (stent markers and marker band on the outer catheter) across the stricture.The radiopaque markers on the stent indicate the ends of the compressed stent and the length of the expanded stent." in addition, an image on the product packaging indicates that the stent length is being measured without stent markers.Updated 'eval code & desc - conclusion1' due to completion of evaluation.

Event Description

It was reported that post successful stent implantation, the vascular stent seemed to be longer than labeled.The stent remains implanted.There was no reported patient injury.

• Brand Name: LIFESTAR 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: 6303847
• MDR Text Key: 66623716
• Report Number: 9681442-2017-00045
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: VIES10060
• Device Lot Number: ANAS0602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• 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