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

Model Number	AVSM10100
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not 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 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.
Event or Problem Description
It was reported that one week post stent graft placement, the patient allegedly experienced arm swelling.Therefore an ultrasound was performed and identified that the stent was compressed and the flow was diminished which caused the arm swelling.The procedure was completed by placing another stent inside the existing stent.The patient's current status was unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an images were provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that one week post stent graft placement, the patient allegedly experienced arm swelling.Therefore an ultrasound was performed and identified that the stent was compressed and the flow was diminished which caused the arm swelling.The procedure was completed by placing another stent inside the existing stent.The patient status was good.
Event or Problem Description
It was reported that one week post stent graft placement, the patient allegedly experienced arm swelling.Therefore an ultrasound was performed and identified that the stent was compressed and the flow was diminished which caused the arm swelling.The procedure was completed by placing another stent inside the existing stent.The patient status was good.
Additional Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as 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 sample was not returned for evaluation.X-ray images and ultrasound images were provided for evaluation.Based on the images a deformation of a stent placed in a fistula could be confirmed.However, due to low resolution of the photos, no further conclusions could be drawn regarding the cause of this deformation.The ultrasound images do not contribute to the evaluation of an alleged deficiency of the stent.Based on the information available a deformation of the placed stent is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential risk was found to be addressed.Based on the instructions for use covered stent specific events that could be associated with clinical complications include compression, kinking and insufficient covered stent expansion.Regarding preparation 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.' in addition, the instructions for use states: 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vein." based on the instructions for use supplied with this product, 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.' h10: d4 (expiry date: 09/2021), g3, h6 (device).H11: h6 (method, result, conclusion).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
• Common Device Name: 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12359060
• Report Number: 9681442-2021-00450
• Device Sequence Number: 19791794
• Product Code: PFV
• UDI-Device Identifier: 00801741106415
• UDI-Public: (01)00801741106415
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: AVSM10100
• Device Catalogue Number: AVSM10100
• Device Lot Number: ANDW3492
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 02/22/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/31/2022; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male