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

Catalog Number AASLE10040

Device Problems Break (1069); Positioning Failure (1158); Misfire (2532)

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

Event Date 09/21/2022

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 vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera vascular covered stent products are identified.Manufacturing review: 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 delivery system was returned for evaluation and the covered stent was found loaded; the force transmitting proximal sheath was broken which indicates high tensile forces were experienced during deployment.It is considered the break of the proximal sheath led to the impossibility to deploy the stent which leads to confirmed results for break and deployment failure.A process related issue could not be found.There was no calcification/tortuosity but the lesion was not pre-dilated.Based on evaluation of the sample, the investigation is confirmed results for break and deployment failure.A definite root cause could not be established based upon the available information.The use of this device to treat aneurysm represents off-label use.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated", and "0.035 inch guidewire of appropriate length, introducer sheath with appropriate inner diameter" should be used; the packaging pictogram indicates the use of an 8f introducer.Holding and handling of the system throughout deployment was found sufficiently described.The instructions for use further states that "the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated".(expiry date: 01/2024).

Event Description

It was reported that during a stent graft placement procedure, the device allegedly partially deployed.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: 15630499
• MDR Text Key: 302781588
• Report Number: 9681442-2022-00307
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136269
• UDI-Public: (01)00801741136269
• 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
• Report Date: 09/27/2022

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: AASLE10040
• Device Lot Number: ANGN3003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/19/2022
• 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
• Patient Sex: Female