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

Model Number	VIUS08020
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer, however, a photo was provided and is under review.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that during preparation for a biliary stent placement procedure, upon opening the outer box and verifying the inner pouch label with the outer box label it was identified that both labels were allegedly different.Reportedly, another device was used to perform the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned sample it was confirmed that the product was not in use and that the product with sealed pouch was packed inside a card box that did not match the lot information on the pouch.Both product lots have been built at the same assembly line, however, it was also confirmed that the packaging issue did not occur at the production site because the complete product lot of the pouch had been sent to the distribution center before the assembly of the product lot on the card box was started.A production related issue could not be identified.Additionally, potential factors that could have led or contributed to the reported event have been evaluated.The event was judged as an isolated incident so previously reported similar complaints have not been reviewed.Both involved lot numbers have been reviewed and a packaging issue at the production site could be excluded.Therefore, this kind of event may be related to shipping, storage, or handling at the hospital.A manufacturing related issue was considered, however, during sample evaluation no manufacturing related issue could be verified.The lot history records have been reviewed with special attention to manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product the potential issue was found addressed.The ifu states: 'visually inspect the bard lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.'.
Event or Problem Description
It was reported that during preparation for a biliary stent placement procedure, upon opening the outer box and verifying the inner pouch label with the outer box label it was identified that both labels were allegedly different.Reportedly, another device was used to perform the procedure.There was no patient contact.

• Brand Name: LIFESTAR BILIARY STENT SYSTEM
• Common Device Name: BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7455200
• Report Number: 9681442-2018-00050
• Device Sequence Number: 1575525
• Product Code: FGE
• UDI-Device Identifier: 04049519005386
• UDI-Public: (01)04049519005386
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: VIUS08020
• Device Catalogue Number: VIUS08020
• Device Lot Number: ANBR3535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1