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

Model Number AVSM10040

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Restenosis (4576)

Event Date 09/26/2022

Event Type  Injury  

Event Description

It was reported through the results of a clinical trial, that sometime post index procedure, using a stent graft, subject developed eighty percent of stenosis and was successfully treated with covera vascular straight stent graft.Approximately one year two months and 14 days post index procedure, event required reintervention.Standard percutaneous transluminal angioplasty (pta) was used to treat the target lesion and the reintervention was successful.The current patient status is not provided.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records 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.D4 (expiry date: 09/2022).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.

Manufacturer Narrative

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 not returned for evaluation.The stent remains implanted.No x-ray images were provided for evaluation.Therefore, the reported restenosis could not be verified.No irregularities or complication occurred during initial stent placement; pre dilation of the lesion and post dilation of the stent was performed.Based on the information available, there were no indication for device deficiency.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use complications and adverse events associated with the use of the covera vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation 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" and "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 vessel." holding and handling for regular deployment was found described.H10: d4 (expiry date: 09/2022).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.H3 other text : device not returned.

Event Description

It was reported through the results of a clinical trial, that sometime post index procedure, using a stent graft, subject developed eighty percent of stenosis and was successfully treated with covera vascular straight stent graft.Approximately one year two months and 14 days post index procedure, event required reintervention.Standard percutaneous transluminal angioplasty (pta) was used to treat the target lesion and the reintervention was successful.The current patient status is not provided.

Manufacturer Narrative

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 not returned for evaluation.The stent remains implanted.No x-ray images were provided for evaluation.Therefore, the reported restenosis could not be verified.No irregularities or complication occurred during initial stent placement; pre dilation of the lesion and post dilation of the stent was performed.Based on the information available, there were no indication for device deficiency.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: relevant labeling applicable for this product was reviewed; it was found that the instruction for use sufficiently address the potential risk associated with the use of the covera vascular covered stent.Based on the instruction for use complications and adverse events may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes obstruction of flow and restenosis of the target vessel.H10: d4 (expiry date: 09/2022).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.H3 other text: device not returned.

Event Description

It was reported through the results of a clinical trial that one year, two months and four days post a straight stent graft placement in the cephalic vein at cephalic vein arch via the right upper arm access, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to pulsatility and prolonged bleeding.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat pulsatility and prolonged bleeding.Treatment reintervention was successful, no new access created, and the outcome was recovered.It was further reported that one year, six months, and twenty days post a straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to decreased access blood flow, pulsatility and prolonged bleeding.Standard percutaneous transluminal balloon angioplasty procedure was performed to treat decreased access blood flow, pulsatility and prolonged bleeding.Treatment reintervention was successful, no new access created, and the outcome was recovered.It was also reported that two years, three months, and thirteen days post a straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to access thrombosis and pulling clots.Standard percutaneous transluminal balloon angioplasty procedure, stent graft placement and thrombectomy of the arteriovenous fistula (aspiration was performed by maintaining negative pressure) were performed to treat access thrombosis and pulling clots.Treatment reintervention was successful, no new access created, and the outcome was recovered.Furthermore, two years, three months, and twenty-two days post a straight stent graft placement, the subject had cephalic vein restenosis which required an arteriovenous access circuit re-intervention due to access thrombosis, proximal cephalic vein stent protruding into large aneurysm, and pulling clots.Standard percutaneous transluminal balloon angioplasty procedure, stent graft placement, surgical revision, open thrombectomy and endovascular thrombectomy for old cephalic vein stent removal were performed to treat access thrombosis, proximal cephalic vein stent protruding into large aneurysm, and pulling clots.Treatment reintervention was successful, no new access created, and the outcome was recovered.Reportedly, there have been no documented device deficiencies, no reported adverse events, and no secondary stage procedures were reported for this subject to date.The current status of the patient is unknown.

• 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: 15697872
• MDR Text Key: 302689957
• Report Number: 9681442-2022-00317
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106385
• UDI-Public: (01)00801741106385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM10040
• Device Catalogue Number: AVSM10040
• Device Lot Number: ANEW0526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• 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 Number: 1
• Treatment: HEPARIN.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic
• Patient Race: White