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

Catalog Number AASLE08080

Device Problems Fracture (1260); Failure to Advance (2524); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us, but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510k number for the covera plus vascular covered stent products is identified.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.(expiry date: 09/2022).

Event Description

It was reported that during stent placement procedure, the device allegedly failed to advance.It was further reported that the device allegedly fracture the first layer of the catheter.Reportedly,the device was removed and another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during stent placement procedure, the device allegedly failed to advance.It was further reported that the device allegedly fracture the first layer of the catheter.Reportedly, the device was removed and another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

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.A definite root cause could not be determined.The intended placement in the superior mesenteric artery represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product, the potential risk was found to be addressed.E.G., the instruction for use states: "in case 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; regarding preparation the instruction for use states: "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.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."the intended placement of the covered stent in superior mesenteric artery represents an off label use of the device.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 arteriosclerotic lesions in iliac and femoral arteries with a reference vessel diameter of 4.5 mm to 9 mm." 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 products that are cleared in the us.The pro code and 510k number for the covera plus vascular covered stent products is identified in d2 and g4.H10: d4 (expiry date: 09/2022), g3, h6 (device).H11: h6 (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.

• 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: 12623865
• MDR Text Key: 277215885
• Report Number: 9681442-2021-00551
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136184
• UDI-Public: (01)00801741136184
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE08080
• Device Lot Number: ANEW4188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• 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