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

Catalog Number	AVFM09080
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.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 or Problem Description
It was reported that during a stent graft placement procedure in the left upper arm fistula, the stent successfully unlocked and began turning then allegedly stopped.It was further reported that allegedly there was a pop sound heard and the physician understood the string probably snapped.Reportedly, the stent allegedly did not deploy at all.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent graft placement procedure in the left upper arm fistula, the stent successfully unlocked and began turning then allegedly stopped.It was further reported that allegedly there was a pop sound heard and the physician understood the string probably snapped.Reportedly, the stent allegedly did not deploy at all.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: 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 returned catheter sample was found in used/ activated condition with fully loaded stent.Inside grip the force transmitting proximal sheath was found broken which made a deployment impossible.The vessel was calcified, the lesion was pre dilated, and system compatible 9f introducer was used for access.The system could be advanced without difficulty.Based on the investigation of the provided information, the investigation is closed as confirmed for break of a force transmitting sheath inside grip, and subsequent deployment failure.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use describes holding and handling of the system throughout the procedure.In particular the instructions 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.' the instructions for use further state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' under required material the instructions 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 8f introducer.H10: g3 h11: h6 (result, conclusion) 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.

• 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: 20627164
• Report Number: 9681442-2024-00384
• Device Sequence Number: 15651528
• Product Code: PFV
• UDI-Device Identifier: 00801741106569
• UDI-Public: (01)00801741106569(17)260524(10)ANJS2603
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/18/2024

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 Expiration Date: 05/24/2026
• Device Catalogue Number: AVFM09080
• Device Lot Number: ANJS2603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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