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

Model Number	AVSM10080
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the delivery system was returned for evaluation and the joint between diving sheath and the distal stent sheath was broken and separated which indicates high tensile forces were experienced during deployment.It is considered the break and separation of the distal sheath led to the impossibility to deploy the stent which leads to confirmed results for break and deployment failure.A process related issue could not be found.It was reported that a hydrophilic guidewire / 9f introducer were used, the lesion was predilated and there was no calcification or tortuosity.Based on available information and evaluation of the returned sample, the investigation is closed with confirmed results for break and failure to deploy as a cascading event.A definite root cause for the reported event could not be found.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions 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 the precautions prior to deployment, the instructions for use state: '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.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation, 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." 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 via left atrioventricular fistula, the stent graft allegedly failed to deploy.It was further reported that delivery system got caught on the stent graft.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: 17285128
• Report Number: 9681442-2023-00258
• Device Sequence Number: 12315545
• Product Code: PFV
• UDI-Device Identifier: 00801741106408
• UDI-Public: (01)00801741106408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/22/2023

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: AVSM10080
• Device Catalogue Number: AVSM10080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/10/2023
• 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 Sex: Unknown