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

Catalog Number	AVSM07040
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reporter that during a stent graft placement procedure, the stent allegedly jumped it was being deployed and was allegedly ended up in the wrong spot.There was no reported patient injury.
Additional 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: 09/2024).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.
Additional Manufacturer Narrative
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 and no images were provided for review which leads to inconclusive result.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system throughout deployment was found sufficiently described.In particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement' and 'slowly and carefully activate the covered stent release mechanism by rotating the large wheel.After deployment of approximately 15 mm, wait several seconds to allow the distal end of the covered stent to fully expand.Ensure the covered stent has wall apposition before completing deployment'.Regarding pta the instructions for use state: 'pre-dilate the stenosis with a pta balloon catheter'.The information provided by bd represents all 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 reporter that during a stent graft placement procedure in the severe stenosis of proximal portion of the right upper extremity arteriovenous graft via an antegrade approach, the stent allegedly jumped while it was being deployed and was allegedly ended up in the wrong spot.The procedure was completed using another device.There was no reported patient injury.
Additional 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 and no images were provided for review which leads to inconclusive result.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.Holding and handling of the system throughout deployment was found sufficiently described.In particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement' and 'slowly and carefully activate the covered stent release mechanism by rotating the large wheel.After deployment of approximately 15 mm, wait several seconds to allow the distal end of the covered stent to fully expand.Ensure the covered stent has wall apposition before completing deployment'.Regarding pta the instructions for use state: 'pre-dilate the stenosis with a pta balloon catheter'.H10: b5, d4 (expiration date: 09/2024).H11: section a through f ¿ the information provided by bd represents all 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 reporter that during a stent graft placement procedure in the severe stenosis of proximal portion of the right upper extremity arteriovenous graft via an antegrade approach, the stent allegedly jumped while it was being deployed and was allegedly ended up in the wrong spot.The procedure was completed using another device.There was no reported patient injury.
Additional 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 and images were provided for review.Provided images demonstrate two overlappingly placed and expanded stents with a digitally drawn brace which may indicate the intended placement site.However, the image of a lying stent cannot confirmed stent jumping when the start position of the deployment is not known which leads to inconclusive result.It was only known that 6f introducer with 0.035" guidewire were used for access.Based on the investigation of the provided information, the investigation is closed as inconclusive.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.Holding and handling of the system throughout deployment was found sufficiently described.In particular the instructions for use state: 'do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement' and 'slowly and carefully activate the covered stent release mechanism by rotating the large wheel.After deployment of approximately 15 mm, wait several seconds to allow the distal end of the covered stent to fully expand.Ensure the covered stent has wall apposition before completing deployment'.Regarding pta the instructions for use state: 'pre-dilate the stenosis with a pta balloon catheter'.H10: d4 (expiration date: 09/2024), g3.H11: h6 (method).H11: section a through f ¿ the information provided by bd represents all 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 reporter that during a stent graft placement procedure in the severe stenosis of proximal portion of the right upper extremity arteriovenous graft via an antegrade approach, the stent allegedly jumped while it was being deployed and was allegedly ended up in the wrong spot.The procedure was completed using another device.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19113676
• Report Number: 9681442-2024-00097
• Device Sequence Number: 18067060
• Product Code: PFV
• UDI-Device Identifier: 00801741106231
• UDI-Public: (01)00801741106231
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AVSM07040
• Device Lot Number: ANGW1236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 07/22/2024; 07/31/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 07/20/2024; 07/29/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown