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

Catalog Number VIUS08080

Device Problems Labelling, Instructions for Use or Training Problem (1318); Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2015

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 further patient details.

Event Description

It was reported that the stent was found to be longer than intended post implantation under fluoroscopy (100 mm instead of 80 mm length).No patient injury was reported.

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.Based on the images provided the reported failure could not be confirmed.The stent length could not be determined as no measurement scale was provided on the images.Furthermore, the stent strut structure is not visible on the images due to the poor resolution and a stent elongation could not be detected.No indication was found that the delivery system or the stent was mislabeled.Therefore, the reported failure could not be reproduced and the investigation will be closed with inconclusive result.Potential product and non product related factors which may have caused or contributed to the reported issue have been considered.Therefore previous investigations of similar complaints have been reviewed.The event may have been associated with an unintended movement of the delivery system during deployment.Also, an excessive compression of the outer catheter during deployment or incorrect holding may cause a change of the stent length.Furthermore, a difficult placement site and tortuous or calcified anatomy may be contributing factors for an irregular stent placement.An insufficient predilation of the lesion could be also a contributing factor.Based on the information available and the evaluation of the images provided, a definitive root cause for the reported complaint could not be determined.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The correct stent deployment is described in the ifu.Furthermore, the ifu states regarding difficulties during deployment: "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit." and "once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or repositioned in the lumen." (b)(4).

• Brand Name: LIFESTAR VASCULAR AND BILIARY STENT SYSTEM
• Type of Device: VASCULAR AND BILIARY 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: 5276609
• MDR Text Key: 33520632
• Report Number: 9681442-2015-00239
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 04049519005423
• UDI-Public: (01)04049519005423(17)180424(10)ANZD2583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080007/S020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2018
• Device Catalogue Number: VIUS08080
• Device Lot Number: ANZD2583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2015
• 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: 58 YR