MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT SYSTEM

Model Number	ZBM07040
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer 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 upon opening of the device packaging, the sterile barrier allegedly was not completely sealed.Reportedly, another vascular stent was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on the investigation of the returned sample an unsealed device packaging was unconfirmed.The pouch was found opened over the whole breadth but the welding seam was clearly visible in good condition indicating that the product had been correctly sealed and the product was actively opened after the sealing process.Furthermore, the safety clip was not part of the sample return, the delivery system was found partly clipped out of the grip, and the stent was found shifted inside the tip which in summary did not match the reported event description which stated the product was not in use.The investigation will be closed with inconclusive result.Based on the available information the investigation was closed with inconclusive result.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 instructions for use (ifu) state: 'visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is open or damaged.' in this case the user reportedly followed the ifu and did not use the product on the patient.The ifu further states: 'during delivery system preparation, ensure that the red safety clip remains in place until the stent is ready to be deployed (.) just prior to stent deployment, remove the red safety clip'.H11:section a through f - 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 upon opening of the device packaging, the sterile barrier allegedly was not completely sealed.Reportedly, another vascular stent was used to complete the procedure.There was no patient contact.

• Brand Name: E-LUMINEXX VASCULAR STENT SYSTEM
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7683655
• Report Number: 9681442-2018-00108
• Device Sequence Number: 13798982
• Product Code: NIO
• UDI-Device Identifier: 04049519009315
• UDI-Public: (01)04049519009315
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P080007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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: 12/22/2020
• Device Model Number: ZBM07040
• Device Catalogue Number: ZBM07040
• Device Lot Number: ANBZ3143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1