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

Model Number	AVFM06100
Medical Device Problem Codes	Break (1069); Misfire (2532); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, images and videos were provided for review.The investigation of the reported event is currently underway.Expiration date: 05/2023.Device pending return.
Event or Problem Description
It was reported that during a stent graft placement procedure, the stent was allegedly partially deployed.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft placement procedure, the stent was allegedly partially deployed.The procedure was completed using another device.There was no reported patient injury.
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.Investigation summary: the delivery system without the stent was returned for evaluation.Even though the partial stent deployment could not be verified based on the device sample, malpositioning of the stent is documented based on x-rays provided.In addition, a force transmitting sheath of the delivery system was found broken, which is considered to have led to the reported deployment issues.Based on evaluation of the sample no indication for a manufacturing related cause could be found.Based on evaluation of the sample breakage of a force transmitting component of the delivery system is confirmed, which is considered to have led to the reported problems during deployment.In addition, malpositioning of the stent is documented on x-ray image material provided.However, a definite root cause for the event experienced by the customer could not be determined based on the information available.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Regarding correct deployment the ifu 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 and accessories, the ifu states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." and states that a 0.035-inch (0.89 mm) guidewire of appropriate length and an introducer sheath with appropriate inner diameter is required.H10: d4 (expiration date: 05/2023), g3, h6 (device).H11: g1, h6 (method, result, conclusion).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
• 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: 14020253
• Report Number: 9681442-2022-00102
• Device Sequence Number: 16802570
• Product Code: PFV
• UDI-Device Identifier: 00801741106453
• UDI-Public: (01)00801741106453
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: AVFM06100
• Device Catalogue Number: AVFM06100
• Device Lot Number: ANFS2295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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