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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT Back to Search Results
Model Number AVSM10100
Device Problems Obstruction of Flow (2423); Material Deformation (2976)
Patient Problems Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Event Date 07/27/2021
Event Type  Injury  
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 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.
 
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 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 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.
 
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.
 
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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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12359060
MDR Text Key267850889
Report Number9681442-2021-00450
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106415
UDI-Public(01)00801741106415
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAVSM10100
Device Catalogue NumberAVSM10100
Device Lot NumberANDW3492
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age34 YR
Patient SexMale
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