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

Model Number AVFM08080

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 07/08/2018

Event Type  Injury  

Manufacturer Narrative

Review of manufacturing records was not performed, as no additional complaint has 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.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 instruction for use (ifu) is adequate for the reported device/patient 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.

Event Description

It was reported through the results of a clinical trial, approximately 5-month post index ((b)(6) 2017) procedure decreased access blood flow was identified.A standard pta was performed to treat the stenosis in the target lesion.It was further reported approximately 8-month post index ((b)(6) 2017) procedure decreased access blood flow with 80% stenosis in the target lesion.Standard pta was used to treat the lesion.It was reported approximately 8-month post index ((b)(6)2017) procedure swelling arm or hand along with 80% stenosis in the target lesion.Standard pta was used to treat the lesion.It was further reported approximately 11-month post index ((b)(6) 2017) procedure decreased access blood flow with 80% stenosis in the target lesion.Standard pta was used to treat the lesion.

Manufacturer Narrative

After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Review of manufacturing records was not performed, as no additional complaint has 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.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 instruction for use (ifu) is adequate for the reported device/patient 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.

Event Description

It was reported through the results of a clinical trial, approximately 5-month post index (b)(6) 2017) procedure decreased access blood flow was identified.A standard pta was performed to treat the stenosis in the target lesion.It was further reported approximately 8-month post index (b)(6) 2017) procedure decreased access blood flow with 80% stenosis in the target lesion.Standard pta was used to treat the lesion.It was reported approximately 8-month post index (b)(6) 2017) procedure swelling arm or hand along with 80% stenosis in the target lesion.Standard pta was used to treat the lesion.It was further reported approximately 11-month post index (b)(6) 2017) procedure decreased access blood flow with 80% stenosis in the target lesion.Standard pta was used to treat the lesion.

• 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: 8796022
• MDR Text Key: 151267136
• Report Number: 2020394-2019-01534
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106521
• UDI-Public: (01)00801741106521
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2017
• Device Model Number: AVFM08080
• Device Catalogue Number: AVFM08080
• Device Lot Number: ANAN2308
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR