MAUDE Adverse Event Report: COOK INC ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G36135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that the zenith renu aaa ancillary graft main body extension "did not open as expected and the final angiogram showed that the right lower renal artery was partially covered.The rx1 26-62 was inserted and the proximal gold markers were placed correctly in respect of the lower right renal artery, approximately 4 mm inferior to most inferior renal artery.The deployment was completed per the instructions for use and there was no off label use of the device.The final angiogram showed up with a partial covering of the right, lower renal artery.Fortunately, the surgeon was able to preserve flow to the renal artery by introducing a stent into the renal artery.No additional adverse effects to the patient were reported.

Manufacturer Narrative

Additional information received: the graft was not altered in any way prior to implant.An amplatz wire guide was used to track the devices over.The patient only had one kidney (right).There is no planning and sizing information.There is no imaging available.The aneurysm was treated with a rx1-26-62 and two (2) additional zlbes as well as an additional stent for the right renal artery in order to keep it open, as it has been partially covered by the rx1-26-62.No procedural notes are available.Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation/evaluation: a visual inspection of the returned device was conducted.In addition, a review of the device history record, the instructions for use, manufacturing instructions, and quality control data was performed.The used delivery system was returned and underwent a device failure analysis.The device failure analysis found several anomalies on the delivery system.A concentric hole was found in the sheath, 2 small dents were found in the tip of the flexor sheath, and the trigger wire distal hole was slightly deformed.These anomalies were likely introduced during the procedure and it was concluded that the device functioned as intended.The device history record was reviewed and no non-conformances were noted.Each zenith device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.As provided in the ifu: inspect the device and packaging to verify that no damage has occurred as a result of shipping.If damage has occurred, do not use the product and return to cook.As the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform angiography to check position as necessary.The physician advises that the procedure was performed per the ifu.Per the ifu, ¿fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft and desired procedural outcome.¿ there is no mention of the removal of the sheath and/or the wire guide.Per the ifu, ¿as the sheath and/or wire guide is withdrawn, anatomy and graft position may change.Constantly monitor graft position and perform angiography to check position as necessary.¿ the ifu also advises, ¿to ensure patency of renal arteries, recognize the proximal graft markers are 2mm below the proximal edge of the graft materials.¿ the physician placed the device approximately 4mm just inferior to the most inferior renal artery.There is no information regarding catheters or the reliant balloon used during the procedure and if these devices met their manufacturing specifications.Based on the information provided, possible causes for this event include medical procedure, user technique, device placement, human anatomy, other device compatibility, device failure, or manufacturing related causes.Based on the lack of imaging and information, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.The appropriate personnel have been notified of this event.Monitoring will continue to be performed for similar complaints.

• Brand Name: ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7155071
• MDR Text Key: 96061746
• Report Number: 1820334-2017-02064
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002361352
• UDI-Public: (01)10827002361352(17)180525(10)6983059
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: G36135
• Device Catalogue Number: RX1-26-62
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 125