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

Catalog Number AASLE07060

Device Problems Fracture (1260); Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.(expiry date: 03/2022).

Event Description

It was reported that during stent graft placement procedure in the right renal artery, the device allegedly had great resistance when introduced.It was further reported that the device allegedly broke the first layer of the catheter in its delivery system.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: 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 covered stent delivery system was returned with a guidewire stuck inside the lumen.The guidewire could not be removed from the delivery system and the reported difficulties to advance the system over the guidewire is confirmed.However, the reason for the guidewire becoming stuck could be reproduced.The detachment of the stability catheter is assessed to be cascading event.No indication for a manufacturing related cause could be found.In this case no indication for use of incompatible accessories were found and the system was flushed prior to use.However, the intended placement site was right renal artery which represents an off-label use.The detached stability sheath is assessed to be a cascading event of the reported advancement problems.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the instruction for use was found to address the potential risk.The instruction for use states: "unusual resistance is met during covered stent system introduction, the system should be removed, and another covered stent system should be used." potential contributing factors were found addressed as the instruction for use states regarding preparation: "using standard endovascular access techniques and fluoroscopy, access the target vessel from a site that permits the straightest possible path to the target lesion and advance an 0.035 inch (0.89 mm) guidewire across the target lesion.For contralateral procedures, a long crossover introducer sheath or guiding catheter must be placed across the aortoiliac bifurcation.Pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated (¿) flush the delivery system through the luer port at the proximal end of the handle with sterile saline until saline drops from the tip of the system that the delivery system should be flushed prior to use until saline drops from the tip of the system." regarding indication for use the instruction for use states: "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." h10: d4 (expiry date: 03/2022), g3 h11: h6(device, method, result, conclusion) 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 : see h10.

Event Description

It was reported that during stent graft placement procedure in the right renal artery, the device allegedly had great resistance when introduced.It was further reported that the device allegedly broke the first layer of the catheter in its delivery system.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11479274
• MDR Text Key: 240125345
• Report Number: 9681442-2021-00140
• Device Sequence Number: 1
• Product Code: PFV
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: ANEQ1332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• 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
• Patient Outcome(s): Other