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

Catalog Number ZVM10040

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 05/2022).

Event Description

It was reported that the inner layer of the packaging was allegedly not sealed and that upon opening, the stent fell on the floor.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Sample evaluation: as part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case the delivery system was returned for evaluation; however, the original package was not returned.Photos showing the alleged deficiency of the packaging was requested but not provided.Therefore, analysis of the reported deficiency of the device package was not possible.Based on the information available and the sample returned the investigation is closed with inconclusive result.A definite root cause could not be determined.Labeling review: current version of instruction for use (ifu) were supplied with this product.In reviewing the current labeling the ifu was found to address the potential risk, as the ifu states: "visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is open or damaged." the catalog number identified has not been cleared in the u.S.But, it is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent products are identified.The information provided by bd 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 bd.

Event Description

It was reported that the inner layer of the packaging was allegedly not sealed and that upon opening, the stent fell on the floor.There was no reported patient contact.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9246290
• MDR Text Key: 179108693
• Report Number: 9681442-2019-00199
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741147128
• UDI-Public: (01)00801741147128
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: ZVM10040
• Device Lot Number: ANDS4340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1