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

Catalog Number AVSM09100

Device Problem Misfire (2532)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, the stent was allegedly not fully deployed and was compacted.There was no reported patient injury.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiry date: 01/2025).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.

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 delivery system was not returned for evaluation and photos were provided which show a fully deployed stent in the vessel with a lying guidewire.The stent struts are not clearly visible such that strut evaluation is not possible but the radio-opaque markers or both ends of the stent can be seen.Contrasted blood can be seen in the vessel.The images cannot confirm the failure of a partial deployment.The investigation leads to inconclusive results for partial deployment.It was reported that the vessel was neither calcified nor tortuous, the lesion was pre-dilated and there was no noticeable damage to the device prior to use.Based on available information and as the sample was not returned, the investigation is closed with inconclusive results for partial deployment.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 instruction for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to partial deployment and high deployment forces.With regards to accessories, the instruction for use states, use "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 and length".Holding the device during deployment is found sufficiently described in the instruction for use.Regarding preparation the instruction for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".H10: b5, d4 (expiry date: 01/2025), g3 h11: e1, 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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure in the cephalic vein, the stent was allegedly not fully deployed and was compacted.There was no reported patient injury.

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 delivery system was returned for evaluation in used condition, the covered stent was fully deployed and missing while the inner catheter was protruding the tip.The deployment mechanism is fully functional.Photos were provided which show a fully deployed stent in the vessel with a lying guidewire.The stent struts are not clearly visible such that strut evaluation is not possible but the radio-opaque markers or both ends of the stent can be seen.Contrasted blood can be seen in the vessel.The images cannot confirm the failure of a partial deployment.The investigation leads to inconclusive results for partial deployment.It was reported that the vessel was neither calcified nor tortuous, the lesion was pre-dilated and there was no noticeable damage to the device prior to use.Based on available information and the evaluation of the returned sample, the investigation is closed with inconclusive results for partial deployment.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 instruction for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to partial deployment and high deployment forces.With regards to accessories, the instruction for use states, use "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 and length".Holding the device during deployment is found sufficiently described in the instruction for use.Regarding preparation the instruction for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated".H10: d4 (expiry date: 01/2025), g3, h2, 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 Description

It was reported that during a stent graft placement procedure in the cephalic vein, the stent was allegedly not fully deployed and was compacted.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: 17479553
• MDR Text Key: 320596589
• Report Number: 9681442-2023-00293
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106361
• UDI-Public: (01)00801741106361
• 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,Followup
• Report Date: 09/27/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: AVSM09100
• Device Lot Number: ANHN1751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/25/2023; 09/27/2023
• Supplement Dates FDA Received: 08/30/2023; 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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