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

Model Number AVSM09060

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provided by bd represents all 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 Description

It was reported that during a stent graft placement procedure, the device allegedly had malfunction.The procedure was completed using another device.There was no reported patient injury.

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 sample was not returned for evaluation.An x-ray photo was provided showing a placed stent.The diameter of the stent in the lower part of the image is significantly smaller than in the upper part.A stent fracture or a cause for the smaller diameter cannot be determined.Based on the x-ray it is confirmed that the self-expanding stent did not expand to its intended diameter on about half of its length.However, the cause for this incomplete expansion could not be determined.Even though a specific device issue was not reported, it is confirmed that the self-expanding stent did not properly expand to its intended length over the entire length.However, a definite root cause for the event experienced by the customer could not be determined.Labeling review: review of the relevant labeling supplied with this product was conducted.However, as no detailed information regarding the nature of the alleged device issue was provided, review of the labeling regarding a specific device issue could not be performed.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 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 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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure, the device allegedly had malfunction.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: COVERA VASCULAR COVERED STENT
• Type of Device: 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: 16771167
• MDR Text Key: 313599886
• Report Number: 9681442-2023-00144
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106347
• UDI-Public: (01)00801741106347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVSM09060
• Device Catalogue Number: AVSM09060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1