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

Catalog Number AVFLE09060

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158); Misfire (2532)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure through right and left superficial femoral artery, the device 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 vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2023).

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 that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent 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 delivery system was returned for evaluation and the stent was found incompletely deployed.The slide block was found no longer connected to proximal sheath.Based on the condition of the sample it is concluded that the slide block getting disconnected from the proximal sheath, 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.A definite root cause is not yet available.The intended use of the devices in the iliac artery represents an off label use.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.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 intended use of the devices in the iliac artery represents an off label use of the covera vascular covered stent.Based on the instructions for use supplied with this product the covera vascular covered stent is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous (av) fistula and at the venous anastomosis of an eptfe or other synthetic av graft.H10: the initial mdr was inadvertently submitted with a g3 date of 03/28/2022.The correct g3 date is 04/07/2022.H10: d4 (expiry date: 10/2023), g3.H11: g1, h6 (result).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.

Event Description

It was reported that during a stent placement procedure through right and left superficial femoral artery, the device allegedly failed to deploy.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure through right and left superficial femoral artery, the device allegedly failed to deploy.The procedure was completed using another device.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 vascular covered stent that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent 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 delivery system was returned for evaluation and the stent was found incompletely deployed.The slide block was found no longer connected to proximal sheath.Based on the condition of the sample it is concluded that the slide block getting disconnected from the proximal sheath, 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.A definite root cause is not yet available.The intended use of the devices in the iliac artery represents an off label use.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.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 intended use of the devices in the iliac artery represents an off label use of the covera vascular covered stent.Based on the instructions for use supplied with this product the covera vascular covered stent is indicated for use in hemodialysis patients for the treatment of stenoses in the venous outflow of an arterio-venous (av) fistula and at the venous anastomosis of an eptfe or other synthetic av graft.H10: b5, d4 (expiry date: 10/2023), g3.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 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: 14157094
• MDR Text Key: 289612561
• Report Number: 9681442-2022-00118
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106088
• UDI-Public: (01)00801741106088
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2022

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: AVFLE09060
• Device Lot Number: ANFX4097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 07/26/2022; 08/04/2022
• Supplement Dates FDA Received: 07/29/2022; 08/11/2022
• 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