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

Model Number AVFM10060

Device Problem Obstruction of Flow (2423)

Patient Problems Pain (1994); Stenosis (2263); Numbness (2415)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the u.S.But, it is similar to the covera vascular covered stent system products that are cleared in the us.The 510 k number and pro code for the pcovera vascular covered stent system products are identified.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 09/2017).

Event Description

It was reported through the results of a clinical trial, approximately 4 months, 4 days post index procedure, 80% stenosis lesion was identified and re-intervention was performed using a standard pta balloon and final residual stenosis was 0%.It was further reported that approximately 4 months, 20 days post index procedure, 60% stenosis lesion was identified and re-intervention was performed using a standard pta balloon and thrombectomy/thrombolysis.Reportedly, approximately 5 months, 17 days post index procedure, 60% stenosis lesion was identified and re-intervention was performed.It was further reported that approximately 1 months, 6 months post index procedure, 50% stenosis lesion was identified and re-intervention was performed using standard pta.

Manufacturer Narrative

H10: manufacturing review: the lot number was provided and a lot history review was performed.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: a physical sample was not available for evaluation, and images have not been provided; the alleged stenosis could not be re produced which led to an inconclusive evaluation result.Based on the information available a definite root cause for the event reported could not be determined.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

Event Description

It was reported through the results of a clinical trial that approximately four months post index procedure, stenosis in the target lesion was identified and standard pta and thrombectomy were performed.Approximately five months and one year six months post index procedure, target lesion stenosis was identified and re-intervention was performed, including pta.Approximately two years seven months post index procedure, an av fistula aneurysm was identified.The patient was admitted to the hospital and the av fistula was resected and an av graft was placed.The patient completed the study.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9936055
• MDR Text Key: 187059145
• Report Number: 9681442-2020-00076
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106590
• UDI-Public: (01)00801741106590
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVFM10060
• Device Catalogue Number: AVFM10060
• Device Lot Number: ANAW3893
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ASPIRIN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR