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

Model Number	AVSM10060
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement procedure for stenosis declot in dialysis graft, only the first couple of struts were allegedly deployed.It was further reported that at one point resistance was felt on the wheel and it was not deploying correctly.Reportedly, the stent was removed from the patient.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 is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2024).
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 delivery system was returned for evaluation, and the force transmitting proximal sheath was broken which indicates high tensile forces were experienced during deployment.Though the stent was returned completely deployed, it is thought that this happened post the reported event since the catheter was still inside the introducer.It is considered the break of the proximal sheath led to the impossibility to completely deploy the stent which leads to confirmed results for break and misfire.It was reported that there was no calcification/tortuosity but the lesion was not pre-dilated.Based on evaluation of the sample, the investigation is closed with confirmed results for break and misfire.A definite root cause could not be established.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated", and "0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter" should be used; the packaging pictogram indicates the use of an 8f introducer.Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiry date: 08/2024).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.
Event or Problem Description
It was reported that during a stent graft placement procedure for stenosis declot in dialysis graft, only the first couple of struts were allegedly deployed.It was further reported that at one point resistance was felt on the wheel and it was not deploying correctly.Reportedly, the stent was removed from the patient.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: 16740805
• Report Number: 9681442-2023-00129
• Device Sequence Number: 6709836
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 05/17/2023

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 Model Number: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANGV3172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White