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

Catalog Number ZVL12100

Device Problems Premature Activation (1484); Misfire (2532); Malposition of Device (2616); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo, an image and a video were provided for review.The investigation of the reported event is currently underway.(expiration date: 05/2024).

Event Description

It was reported that during a stent placement procedure in the lower extremity via a femoral vein puncture to treat deep venous thrombosis, the stent allegedly got deployed prematurely.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure in the lower extremity via a femoral vein puncture to treat deep venous thrombosis, the stent allegedly deployed partially.It was further reported that the device allegedly had malposition issues.Reportedly, the device allegedly difficult to advance.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The lot history records of this lot were 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.Investigation summary: the sample was not returned but x-ray images were provided demonstrating a partially released stent inside patient; however, a single image taken during deployment action with a partially released stent does not confirm the failure of a partial deployment.The intended area to be covered is not known on the image, so that a statement in regards to misplacement cannot be made.Based on the available information and analysis of the provided photos and video, the investigation is inconclusive for reported issue.A definite root cause for the reported issue could not be identified.The intended use of this stent in the venous system represents off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding general warning, the instructions for use states "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".With regards to general directives, the instructions for use states "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".Regarding procedural access, the ifu states "the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the femoral route, insert a 0.035¿ (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to indications for use, the instructions for use states that the stent is to be used on femoral and iliac arteries.Based on reported information, the intended placement site for this stent was the venous system which represents off-label use.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 VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14710588
• MDR Text Key: 294527498
• Report Number: 9681442-2022-00183
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00801741146527
• UDI-Public: (01)00801741146527
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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: ZVL12100
• Device Lot Number: ANFS2511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 58 KG