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

Model Number	AVSM10060
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported during a stent placement procedure, the device allegedly failed to deploy.It was further reported that the wheel allegedly broke.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the delivery system was returned for evaluation, and it was confirmed that the covered stent was not completely deployed.However, a cause for the partial deployment could not be determined.The slide block inside the delivery system, as well as any other components were found to be intact.No indication for an alleged break, as reported by the customer could be found.Based on evaluation of the sample, it could be confirmed that the covered stent could not be deployed completely.However, a definite root cause could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instruction for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instruction for use states: "maintain a stationary hold on the white stability sheath during covered stent deployment (¿).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension." regarding preparation the instruction for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.".
Event or Problem Description
It was reported during a stent placement procedure, the device allegedly failed to deploy.It was further reported that the wheel allegedly broke.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: 15101230
• Report Number: 9681442-2022-00219
• Device Sequence Number: 4587993
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/22/2022

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: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/24/2022
• 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: Male