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

Catalog Number AASLE10080

Device Problem Material Deformation (2976)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

It was reported that during a transjugular intrahepatic portosystemic shunt placement procedure, the stent allegedly had shorter length after deployment.The procedure was completed using another device.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 system that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2023).

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 system that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 is not available for evaluation.Images were provided demonstrating two placed stents with poor resolution; a strut evaluation for stent elongation/ foreshortening was not possible.Adequate scaling information was not provided so that an accurate length measurement was not possible which leads to inconclusive evaluation result.Based on the provided information, the investigation is inconclusive for reported issue.A definite root cause for the reported event could not be determined.The reported indication represents an off-label use of the device.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instruction for use state: 'during covered stent release, do not hold the 30 cm long distal catheter assembly segment as it must be free to move and slide into the white stability sheath.', and ' (.) 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 (segment between left and right hand on illustration) relaxed and avoid tension.' in regard to anatomy the instruction for use state: 'make sure that the proximal covered stent end is positioned in a straight section of the vessel during deployment'.In regard to pta the instruction for use state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' in regard to choose of the appropriate stent length the instruction for use state: 'ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the non-diseased segment of the vessel.' under potential complications and adverse events, the instruction for use state 'inaccurate deployment'.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.H10: d4 (expiry date: 09/2023), g3 h11: section a through f ¿ the information provide by bd represents all 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 : device not returned.

Event Description

It was reported that during a transjugular intrahepatic portosystemic shunt placement procedure, the stent allegedly had shorter length after deployment.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: 14586675
• MDR Text Key: 293502684
• Report Number: 9681442-2022-00171
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136283
• UDI-Public: (01)00801741136283
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE10080
• Device Lot Number: ANFW2040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2022
• 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: 21 YR
• Patient Sex: Female
• Patient Weight: 45 KG