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

Model Number	AVFM07060
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 returned to the manufacturer for evaluation.The returned sample was found with used deployment mechanism and with undeployed stent.A force transmitting sheath was found broken inside the system which made a successful deployment impossible.In addition, the sheath was found kinked in the position of break but the relation of the kink to the break was not known which leads to confirmed result for break of a force transmitting piece of catheter leading to deployment failure.A process related issue could not be identified.In this case the lesion was pre dilated, and the vessel was not tortuous/ calcified.A 6f introducer sheath was in use for access.A damage was not reported.Therefore, the investigation is confirmed for the reported issues.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed.', and 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' in regards to accessories the instruction for use state: '0.035 inch guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery system.Introducer sheath with appropriate inner diameter'; the packaging pictograms indicate the use of a 0.035" guidewire, and a 8f introducer sheath.The instruction for use closely describes holding and handling of the system throughout deployment; in particular the instruction for use state: 'during covered stent release do not hold the 30 cm long distal catheter assembly segment as it must be free to move and slide into the white stability sheath.' under delivery system specific events that could be associated with clinical complications the instruction for use state: '(¿) failure to deploy (¿)'.(expiry date: 09/2022).
Event or Problem Description
It was reported that during a stent placement procedure in the cephalic vein, the stent allegedly failed to deploy.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13591633
• Report Number: 9681442-2022-00051
• Device Sequence Number: 5819686
• Product Code: PFV
• UDI-Device Identifier: 00801741106477
• UDI-Public: (01)00801741106477
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 01/28/2022

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: AVFM07060
• Device Catalogue Number: AVFM07060
• Device Lot Number: ANEW4156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/24/2022
• 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 Sex: Unknown