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

Catalog Number AASLE07060

Device Problems Break (1069); Misfire (2532)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure in mesenteric artery via right brachial artery approach, the stent allegedly misfired.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified in d2 and g4.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: the physical sample was not returned for evaluation and photos were not provided which leads to inconclusive results.It was reported that a 0.035" guidewire with 8f introducer was used, there was no need to dilate due to risk of injury and the device was locked during use.Based on available information, the investigation is closed with inconclusive results for partial deployment.A definite root cause for the reported event could not be determined.The reported indication represents off-label use.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use closely describes holding and handling of the system throughout deployment.With regards to preparation and accessories, the instruction for use states "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated", and "0.035 inch guidewire of appropriate length, introducer sheath with appropriate inner diameter" should be used; the packaging pictogram indicates the use of an 8f introducer.The instruction for use further state: "prior to covered stent deployment, unlock the red safety lock by pressing it down and pulling it back towards the end of the grip from the locked position into the unlocked position.Ensure that the red safety lock is completely retracted and that the symbol for the unlocked position is fully visible." the covera plus vascular covered stent is indicated for the treatment of stenoses in the upper extremity venous outflow of patients dialyzing with an arterio-venous (av) access graft or fistula and for the treatment of atherosclerotic lesions in iliac and femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm.The instruction for use states that "the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated." device not returned.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified in d2 and g4.H10: 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: the physical sample was returned for evaluation.The delivery system was returned for evaluation and the covered stent was found partially deployed; the force transmitting proximal sheath was broken which indicates high tensile forces were experienced during deployment.It is considered the break of the proximal sheath led to the impossibility to completely deploy the stent which leads to confirmed results for break and misfire.It was reported that a 0.035" guidewire with 8f introducer was used, there was no need to dilate due to risk of injury and the device was locked during use.Based on evaluation of the sample, the investigation is closed with confirmed results for break and partial deployment.A definite root cause could not be established.The reported indication represents off-label use.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describes holding and handling of the system throughout deployment.With regards to preparation and accessories, the instructions for use states "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated", and "0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter" should be used; the packaging pictogram indicates the use of an 8f introducer.The instructions for use further state: "prior to covered stent deployment, unlock the red safety lock by pressing it down and pulling it back towards the end of the grip from the locked position into the unlocked position.Ensure that the red safety lock is completely retracted and that the symbol for the unlocked position is fully visible." the covera plus vascular covered stent is indicated for the treatment of stenoses in the upper extremity venous outflow of patients dialyzing with an arterio-venous (av) access graft or fistula and for the treatment of atherosclerotic lesions in iliac and femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm.The instructions for use states that "the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated".H10: d4 (expiry date: 04/2024), g3, h6 (device).H11: h6 (method, result, conclusion).H11: section a through f - 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 during a stent placement procedure in mesenteric artery via right brachial artery approach, the stent allegedly misfired.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT
• Type of Device: VASCULAR COVERED 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: 16136505
• MDR Text Key: 308242412
• Report Number: 9681442-2022-00389
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136122
• UDI-Public: (01)00801741136122
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE07060
• Device Lot Number: ANGR3401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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