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

Model Number AVSL06060

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158); Retraction Problem (1536); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/22/2022

Event Type  Death  

Manufacturer Narrative

The catalog number identified has not been cleared in the u.S.But, it is similar to the covera plus covered stent products that are cleared in the us.The 510 k number and pro code for the covera plus covered stent products are identified respectively.The lot number for the device was provided.The device history records are currently under review.The device is pending return.The investigation is currently underway.(expiry date: 07/2023).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 two stent grafts placement procedure in the common iliac arteries, using the covered endovascular reconstruction of aortic bifurcation (cerab) technique, the first stent graft was successfully placed in the common iliac; however, during an attempt to implant the second stent graft, the health care provider (hcp) allegedly experience resistance during deployment and decided to remove the delivery system.It was further reported that an alleged retraction problem occurred resulting in the loss of access site as the guidewire/sheath/device were removed as a single unit.The hcp then decided to halt the procedure and performed a femoral-femoral bypass the following day to conclude treatment.Reportedly, the patient then had three more surgeries, was intubated, approximately three days later the patient expired.The relationship between the device related issues and the patient impact is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the covera plus covered stent products that are cleared in the us.The 510 k number and pro code for the covera plus covered stent products are identified in d2 and g5 respectively.H10: the lot number for the device was provided.The device history records are currently under review.The device was received for evaluation.The investigation is currently underway.H10: d4 (expiry date: 07/2023).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.

Event Description

It was reported that during two stent grafts placement procedure in the common iliac arteries, using the covered endovascular reconstruction of aortic bifurcation (cerab) technique, the first stent graft was successfully placed in the common iliac; however, during an attempt to implant the second stent graft, the health care provider (hcp) allegedly experience resistance during deployment and decided to remove the delivery system.It was further reported that an alleged retraction problem occurred resulting in the loss of access site as the guidewire/sheath/device were removed as a single unit.The hcp then decided to halt the procedure and performed a femoral-femoral bypass the following day to conclude treatment.Reportedly, the patient then had three more surgeries, was intubated, approximately three days later the patient expired.The relationship between the device related issues and the patient impact is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the u.S.But, it is similar to the covera plus covered stent products that are cleared in the us.The 510 k number and pro code for the covera plus covered stent products are identified in d2 and g5 respectively.H10: 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.Additional complaint has not been reported for this lot, previously.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.The reported problems to remove the delivery system and the loss of the access could not be reproduced.The reported use of the device for endovascular reconstruction of the aortic bifurcation represents an off-label use.A definite root cause is not yet available and will be documented upon being identified.H10: d4 (expiry date: 07/2023), h6 (device code, investigation, conclusion).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 two stent grafts placement procedure in the common iliac arteries, using the covered endovascular reconstruction of aortic bifurcation (cerab) technique, the first stent graft was successfully placed in the common iliac; however, during an attempt to implant the second stent graft, the health care provider (hcp) allegedly experience resistance during deployment and decided to remove the delivery system.It was further reported that an alleged retraction problem occurred resulting in the loss of access site as the guidewire/sheath/device were removed as a single unit.The hcp then decided to halt the procedure and performed a femoral-femoral bypass the following day to conclude treatment.Reportedly, the patient then had three more surgeries, was intubated, approximately three days later the patient expired.The relationship between the device related issues and the patient impact is unknown.

• 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: 15271852
• MDR Text Key: 298371535
• Report Number: 9681442-2022-00246
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106644
• UDI-Public: (01)00801741106644
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: AVSL06060
• Device Catalogue Number: AASLE06060
• Device Lot Number: ANFU3100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• 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 Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 58 KG