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

Catalog Number AVFLE10060

Device Problem Misfire (2532)

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

Event Date 06/21/2023

Event Type  malfunction  

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: 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.H10: d4 (expiry date: 01/2024).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.Device pending return.

Event Description

It was reported that during a stent graft placement procedure in the right subclavian artery via groin access, the stent allegedly partially deployed.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure in the right subclavian artery via groin access, the stent allegedly partially deployed.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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the sample was returned for evaluation.The returned sample was found in used condition with partially deployed covered stent.During evaluation testing, the covered stent could be successfully deployed on the table without issue which leads to inconclusive evaluation result.The product was used in the subclavian artery which is off label and which was considered a significant factor; a 10f sheath was used for access.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use closely describes holding and handling of the system during deployment.Particularly the instruction for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment (.)'.The instruction for use further state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter (.)'.And 'the safety and effectiveness of the device when placed across an aneurysm or a pseudo-aneurysm has not been evaluated.', and '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.' the packaging pictograms indicate the use of a 8f introducer, and 0.035" guidewire.H10: d4 (expiry date: 01/2024), 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.

• 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: 17332134
• MDR Text Key: 319200310
• Report Number: 9681442-2023-00272
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106149
• UDI-Public: (01)00801741106149
• 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
• Report Date: 08/16/2023

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: AVFLE10060
• Device Lot Number: ANGN2850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 08/18/2023
• 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: Male