MAUDE Adverse Event Report: COOK INC ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Kinked (1339)

Patient Problems Other (for use when an appropriate patient code cannot be identified) (2200); No Code Available (3191)

Event Date 05/06/2015

Event Type  Injury  

Event Description

On (b)(6) 2010, an (b)(6) male patient underwent evar.A molding balloon was used without difficulty or complications.Dilation of the right fenestration and right renal artery was performed before device deployment.A zenith alignment stent was placed in the left renal artery and a zenith alignment stent was placed in the left renal artery and a zenith alignment stent was placed in the right renal artery.There were no difficulties during deployment.The grafts and fenestrated renal arteries were patent with no kink after the graft was completely implanted.A type iii endoleak was treated with ballooning.Core lab analysis of the completion angiogram concurred with this assessment but noted an endoleak of unknown type.(b)(6) 2010 (one day post-procedure): core lab analysis of a post-procedure ct scan noted that the endovascular graft and fenestrated and stented renal arteries were patent and intact with no evidence of a kink.An endoleak of unknown type was noted.The patient was discharged on (b)(6) 2010.(b)(6) 2010 (29 days post-procedure): at a one month follow up ct scan the core lab review found that the endovascular graft and fenestrated and stented renal arteries were patent and intact with no evidence of a kink or endoleak.(b)(6) 2010 (195 days post procedure): at a six month follow up imaging site review of a kink was noted in the left iliac leg graft.At the core lob review, no kink was noted.(b)(6) 2011 (363 days post procedure): at 12 month follow up imaging site no kink was noted.At the core lab review, no kink was noted.(b)(6) 2012 (734 days post procedure): at two year follow up imaging site review, no kink was noted.At the core lab review, no kink was noted.(b)(6) 2013 (1100 days post procedure): at three year follow up imaging site review, no kink was noted.At core lab review, no kink was noted.(b)(6) 2014 (1469 days post procedure): at four year follow up imaging site review, no kink was noted.At core lab review, no kink was noted.(b)(6) 2015 (1487 days post procedure): at five year follow up imaging site review, a mild kink was noted in the left iliac leg graft.The core lab review is not available yet.The patient did not require additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu) and trends was conducted during the investigation.Each zenith device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings & precautions, and the correct deployment procedure.In regards to occlusions, the ifu lists several warnings/precautions that, if followed, could prevent this failure mode from occurring or lessen the associated effects; anatomical criteria.Anatomical conditions.Importance of accurate placement.Specific to this case zenith ifus state: "patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." "vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization." the provided imaging in this case was sent for outside expert clinical review.The reviewer concluded that the left limb was bent, rather than kinked, in accordance to their definition of kinked (narrowing the sent lumen more than 50%).The event was trended as low impact to the patient, as no additional treatment was reported.There is no evidence to suggest that the device was not manufactured to specification.Per quality engineering risk assessment, additional action is not required at this time.We will continue to monitor for similar complaints and notify the appropriate internal personnel.

Event Description

On (b)(6) 2010, an (b)(6) year old male patient underwent evar.A molding balloon was used without difficulty or complications.Dilation of the right fenestration and right renal artery was performed before device deployment.A zenith alignment stent was placed in the left renal artery and a zenith alignment stent was placed in the right renal artery.There were no difficulties during deployment.The grafts and fenestrated renal arteries were patent with no kink after the graft was completely implanted.A type iii endoleak was treated with ballooning.Core lab analysis of the completion angiogram concurred with this assessment but noted an endoleak of unknown type.On (b)(6) 2010 (one day post-procedure): core lab analysis of a post-procedure ct scan noted that the endovascular graft and fenestrated and stented renal arteries were patent and intact with no evidence of a kink.An endoleak of unknown type was noted.The patient was discharged on (b)(6) 2010.On (b)(6) 2010 (29 days post-procedure): at one-month follow-up ct scan the core lab review found that the endovascular graft and fenestrated and stented renal arteries were patent and intact with no evidence of a kink or endoleak.On (b)(6) 2010 (195 days post-procedure): at a six-month follow-up imaging site review a kink was noted in the left iliac leg graft.At the core lab review, no kink was noted.On (b)(6) 2011 (363 days post-procedure): at 12-month follow-up imaging site review no kink was noted.At the core lab review, no kink was noted.On (b)(6) 2012 (734 days post-procedure): at two-year follow-up imaging site review, no kink was noted.At the core lab review, no kink was noted.On (b)(6) 2013 (1100 days post-procedure): at three-year follow-up imaging site review, no kink was noted.At core lab review, no kink was noted.On (b)(6) 2014 (1469 days post-procedure): at four-year follow-up imaging site review, no kink was noted.At core lab review, no kink was noted.On (b)(6) 2015 (1847 days post-procedure): at five-year follow-up imaging site review, a mild kink was noted in the left iliac leg graft.The core lab review is not available yet.The patient did not require and additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
• 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 ; 8128294891
• MDR Report Key: 4841576
• MDR Text Key: 17695696
• Report Number: 1820334-2015-00363
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TFLE-16-71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/06/2015
• Device Age: 7 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2008
• 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): Other
• Patient Age: 82 YR
• Patient Weight: 81