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

Model Number AVSM09060

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 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

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 stent delivery system was returned for evaluation and the slide block of this device, a force transmitting component was found no longer connected to the 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 partial deployment of the stent.Two pictures were provided for evaluation; however no additional information was found, apart from the information obtained from the evaluation of the sample.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 together with the partial deployment of the stent as a cascading event.A definite root cause is not yet available.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: "if unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used".With regards to preparation and accessories, 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", "flush the delivery system through the luer port at the proximal end of the handle with sterile saline until the saline exits the tip of the system" 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.(expiry date: 10/2023).

Event Description

It was reported that during a stent graft placement procedure through left arteriovenous graft, the stent allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.

• 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: 15101772
• MDR Text Key: 302433204
• Report Number: 9681442-2022-00221
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106347
• UDI-Public: (01)00801741106347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2022

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 Model Number: AVSM09060
• Device Catalogue Number: AVSM09060
• Device Lot Number: ANFX3144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/26/2022
• 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 Age: 86 YR
• Patient Sex: Female