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

Catalog Number	AVSM10060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement procedure, the stent allegedly cracked.It was further reported that the healthcare professional will be re-stenting to avoid migration of fragments in the body.There was no reported patient injury.
Additional 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 sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.Device not returned.
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 device was not returned for evaluation.No images were provided which lead to inconclusive results.Based on information available and as no device sample was returned for evaluation, the investigation is closed with inconclusive result.A definite root cause for the issue experienced by the customer could not be identified.Labeling review: the relevant labeling for this product was reviewed.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 stent fracture.Holding and handling of the system throughout deployment was found sufficiently described.With regards to precautions, the instruction for use states "post dilation of the covered stent must be performed using an appropriately sized pta balloon catheter to avoid damage to the covered stent.The covered stent cannot be post dilated beyond its labelled diameter".The instruction for use also states fracture as a potential complication of the use of covered stents.H10: g3 h11: h6 (method) 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, the stent allegedly cracked.It was further reported that the healthcare professional will be re-stenting to avoid migration of fragments in the body.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 device was not returned for evaluation, and no images were provided which led to inconclusive results.Based on information available and as no device sample was returned for evaluation, the investigation is closed with inconclusive result.A definite root cause for the issue experienced by the customer could not be identified.Labeling review: the relevant labeling for this product was reviewed.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 stent fracture.Holding and handling of the system throughout deployment was found sufficiently described.With regards to precautions, the instructions for use states "post dilation of the covered stent must be performed using an appropriately sized pta balloon catheter to avoid damage to the covered stent.The covered stent cannot be post dilated beyond its labelled diameter".The instructions for use also states fracture as a potential complication of the use of covered stents.H10: (expiration date: 04/2024).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, the stent allegedly cracked.It was further reported that the healthcare professional will be re-stenting to avoid migration of fragments in the body.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: 16982330
• Report Number: 9681442-2023-00198
• Device Sequence Number: 6771623
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/20/2024

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 Catalogue Number: AVSM10060
• Device Lot Number: ANGR1548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/13/2023; 08/06/2024
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/15/2023; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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