MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT

Catalog Number AASME07080

Device Problem Malposition of Device (2616)

Patient Problem Injury (2348)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: 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: several dicom images were provided for evaluation.A malposition of the stent leading to an occlusion of the access to the internal iliac artery can be confirmed.A deficiency of the placed stent cannot be identified.Based on the evaluation of the x-rays provided the partial coverage of the ostium of the internal iliac artery can be confirmed.However, no deficiency of the placed stent can be identified.Malpositioning of the stent may be related to inadequate placement technique as well as difficult patient anatomy or challenging placement site.Based on the information available and the evaluation of the x-ray images a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the deployment procedure of the covered stent.The ifu states: "under radiographic guidance, advance the delivery system over the guidewire past the target lesion and then pull back slightly on the entire system to attain correct positioning of the radiopaque markers.Use the radiopaque covered stent ends to center the covered stent across the lesion.(.) with your free hand, maintain a stationary hold on the white stability sheath during covered stent deployment and adjust for placement accuracy if necessary (.).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension.(.).Do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement.(.) for accurate placement, subtle repositioning may be performed during initial wheel activation while the covered stent is still compressed in the catheter." potential complications and adverse events were found to be addressed; e.G.The ifu states: delivery system specific events that could be associated with clinical complications may include inaccurate deployment.Device expire date: 10/2022.

Event Description

It was reported that a 7x80 mm covered stent supposed to be placed in the left external iliac artery, was misplaced.The indication for the stent placement was a 50% stenosis of the left external iliac artery, nearly over the entire length of the vessel.Pta of the stenosis was performed using a 6x80 mm balloon.Control angiographie showed that the stenosis was almost completely removed, however, due to dissection of the dilated area, a 7x80 covered stent was implanted.According to angiographic criteria placement of the stent was planed, so that the arteria iliaca interna should not be covered.After placement of the 7x80 covered stent, the stenosis was completely resolved.However, the branch of the internal iliac artery was found to be almost completely covered.Additional balloon dilation and placement of an additional stent was required to restore flow into the branches of the internal iliac arteries.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10269914
• MDR Text Key: 198692956
• Report Number: 9681442-2020-00145
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741135880
• UDI-Public: (01)00801741135880
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Catalogue Number: AASME07080
• Device Lot Number: ANEN1055
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/14/2020
• 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
• Treatment: ASPIRIN, CLOPIDOGREL, AND SIMVASTATIN
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 110