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

Catalog Number AASME07100

Device Problems Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure in axillary artery via brachial artery, the guidewire allegedly stuck at the distal part of delivery system during the removal of delivery system.Reportedly, the stent was deployed.There was no reported patient injury.

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.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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).

Event Description

It was reported that during a stent graft placement procedure in axillary artery via brachial artery, the guidewire allegedly stuck at the distal part of delivery system during the removal of delivery system.Reportedly, the stent was deployed.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: 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 covered stent delivery system was returned.The covered stent was completely deployed as reported.The inner catheter was found to be broken off almost over its entire length, which is reasonably suggested to be a result of the reported difficulties to remove the delivery system post stent deployment.As there was no reported breakage of the inner catheter it is considered that the inner catheter may be caught and stuck on guidewire.The guide wire used by the customer was not returned.The kink protection of the delivery system returned was found detached, which could be a consequence of manipulation during the attempt to remove the delivery system over the guidewire respectively from the patient.In addition, a photo was provided of the distal part of the delivery system lying in the surgical field and the inner catheter can be seen still attached to the introducer outside the patient.It was reported that that the lesion was calcified; an 8fr introducer was used, the diameter of the guidewire was not reported.Based on evaluation of the delivery system returned for evaluation, breakage of the inner catheter is confirmed, which is considered to be a direct consequence of the reported difficulties to remove the delivery system over the guidewire.However, based on the information available, a definite root cause for the reported issue could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.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." and "flush the delivery system through the luer port at the proximal end of the handle with sterile saline until saline drops from the tip of the system." as documented in the instructions for use, the covera plus delivery system is compatible with 0.035 inch (0.89 mm) guidewires and 8f or 9f introducer sheaths.H10: d4 (expiry date: 02/2023).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.

• 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: 16625859
• MDR Text Key: 312295049
• Report Number: 9681442-2023-00103
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741135897
• UDI-Public: (01)00801741135897
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• 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: ANFP0832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Female