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

Model Number	ZBM08040
Medical Device Problem Codes	Premature Activation (1484); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that during treatment of a fistula in the arm, the stent allegedly prematurely deployed with the safety clip in place after advancing through the introducer sheath and while entering the patient anatomy.It was further reported that the device was removed without incident and another delivery system was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during treatment of a fistula in the arm, the stent allegedly prematurely deployed with the safety clip in place after advancing through the introducer sheath and while entering the patient anatomy.It was further reported that the device was removed without incident and another delivery system was used to complete the procedure.There was no reported patient injury.
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.Investigation summary: based on the investigation of the returned delivery system a premature deployment could not be confirmed.The sample was returned with fully activated deployment mechanism, the safety clip was found removed, and the stent was missing.It was not known when the stent was actively released.The investigation led to an inconclusive evaluation result.A definite root cause for the reported event could not be determined.The reported application represented an off label use of the device.Labeling review: based on the lot number reported the instructions for use (ifu) were supplied with the product.In reviewing the labeling supplied with this product, it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu state: '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.', 'pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician.', and 'visually inspect the bard e luminexx vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment.', and 'flush the stent delivery system with sterile saline (.).' regarding accessories the ifu state: 'the bard e luminexx vascular stent is only compatible with a 0.035¿ (0.89 mm) guidewire.', and 'the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.' the reported application represented an off label use of the device.Based on the ifu supplied with this product the bard e luminexx vascular stent is indicated for the treatment of iliac occlusive disease (.) of the common and/or external iliac arteries.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.

• Brand Name: E-LUMINEXX STENT SYSTEM
• Common Device Name: BILIARY AND VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9264050
• Report Number: 9681442-2019-00206
• Device Sequence Number: 3671505
• Product Code: FGE
• UDI-Device Identifier: 04049519009377
• UDI-Public: (01)04049519009377
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: ZBM08040
• Device Catalogue Number: ZBM08040
• Device Lot Number: ANDQ2574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 49