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

Model Number AVSM10060

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

Patient Problems Aneurysm (1708); Stenosis (2263)

Event Date 05/10/2018

Event Type  Injury  

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.(expiry date: 11/2017).Device not returned.

Event Description

It was reported through the results of a clinical trial, that approximately ten months and twenty three days post index procedure, the patient developed 70% of target lesion stenosis.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The subject had an adverse event of aneurysm on av fistula and recovering.The current patient status was not provided.

Event Description

It was reported through the results of a clinical trial, that approximately ten months and twenty three days post index procedure, the patient developed 70% of target lesion stenosis.A standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.The subject had an adverse event of aneurysm on av fistula and recovering.The current patient status was not provided.

Manufacturer Narrative

H10: manufacturing review: the lot history records have been 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 and x-ray images were not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.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." 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
• 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 Key: 12445528
• MDR Text Key: 270483947
• Report Number: 9681442-2021-00496
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANAY0055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• 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 Number: 1
• Treatment: HEPARIN AND WARFARIN.; HEPARIN AND WARFARIN.; HEPARIN AND WARFARIN
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White