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

Catalog Number AASME07100

Device Problems Misfire (2532); Malposition of Device (2616)

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

Event Date 07/08/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure for venous outflow stenoses of arteriovenous fistula via brachial access, the stent allegedly jumped and dislodged.It was further reported that the stent was allegedly partially deployed.Reportedly, the stent was removed and the procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2024).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.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g4.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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the device was not returned for evaluation.A photo was provided, showing the distal end of the delivery systems catheter in the operation theatre.Based on the photo no partial stent deployment did occur; however, there was a gap between the atraumatic tip and the end of the stent sheath of about 10 mm, while the stent is still loaded in the sheath.Based on the photo, no further conclusions can be drawn regarding the alleged device deficiency.No difficult patient anatomy was reported.The alleged device deficiency could not be verified, as the device was not returned for evaluation.Based on information available and as the device sample was not returned for evaluation, the investigation is closed with inconclusive result.A definite root cause for the alleged device deficiency could not be identified.Labeling review: the relevant labeling for this product was reviewed and the potential issue was found addressed.Regarding preparation the instructions for use states: "using standard endovascular access techniques and fluoroscopy, access the target vessel from a site that permits the straightest possible path to the target lesion and advance an 0.035 inch (0.89 mm) guidewire of appropriate length across the target lesion.Holding and handling of the system was found described.D4 (expiry date: 09/2024).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.

Event Description

It was reported that during a stent placement procedure for venous outflow stenoses of arteriovenous fistula via brachial access, the stent allegedly jumped and dislodged.It was further reported that the stent was allegedly partially deployed.Reportedly stent was removed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: COVERA PLUS 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: 17457516
• MDR Text Key: 320581735
• Report Number: 9681442-2023-00289
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741135897
• UDI-Public: (01)00801741135897
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME07100
• Device Lot Number: ANGW0607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• 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