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

Catalog Number AASLE06040

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158)

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

Event Date 12/23/2022

Event Type  malfunction  

Event Description

It was reported that during stent placement procedure for hepatic artery aneurysm, the stent allegedly failed to deploy.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified.A voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera¿ vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.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 sample was not returned for evaluation and image was not provided for review.The product was used off label in the hepatic artery for aneurysm treatment.Based on evaluation of the provided information the investigation is inconclusive for deployment failure.A definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instructions for use states '(¿) maintain a stationary hold on the white stability sheath during covered stent deployment (¿).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.' regarding preparation 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.' the instructions for use further state: '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.', and 'the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated.' (expiry date: 11/2023).Device not returned.

Event Description

It was reported that during stent placement procedure for hepatic artery aneurysm, the stent allegedly failed to deploy.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent are identified in d2 and g4.H10: a voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera¿ vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.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 stent delivery system of a covered stent was returned for evaluation.The slide block, a force transmitting component was no longer connected to the proximal sheath.The disconnection of the slide block is considered to have led to the reported impossibility to deploy the stent.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.The product was used off label.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instructions for use states '(¿) maintain a stationary hold on the white stability sheath during covered stent deployment (¿).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.' regarding preparation 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.' the instructions for use further state: '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.', and 'the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated.'.H10: d4 (expiry date: 11/2023), 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.H3 other text : see h10.

• 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: 16476331
• MDR Text Key: 310616912
• Report Number: 9681442-2023-00058
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136061
• UDI-Public: (01)00801741136061
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE06040
• Device Lot Number: ANFY2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• 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
• Removal/Correction Number: RES 91359
• Patient Sequence Number: 1