MAUDE Adverse Event Report: COOK INC UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 05/01/2015

Event Type  Injury  

Event Description

On (b)(6) 2012 a (b)(6) male patient underwent aaa repair.The main body was implanted 6mm distal from the renal artery due to adjustment gap of sealing stent and flex of proximal neck.After stent placement, proximal type i endoleak occurred, and another manufactures' stent was placed inside of the main body to treat endoleak.After placement of the other manufacturer's stent, no endoleak was confirmed.

Manufacturer Narrative

(b)(4).Event is currently under investigation.On an unknown date, enlargement of the aneurysm was confirmed due to type ii (from lumbar artery) and lumber artery embolization was performed.Sometime in (b)(6) 2015, enlargement of the aneurysm was confirmed due to proximal type i endoleak.On (b)(6) 2015, the patient complained about abdominal pains.Impending rupture was suspected and evar was performed urgently.The physician performed touch up ballooning to proximal neck, however the endoleak would not resolved.Therefore, another manufacture's stent was implanted from just below renal artery.The amount of leakage was decreased, so the procedure completed.There have been no adverse effect to the patient reported.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history and the instructions for use was conducted during the investigation.No detailed information about the product, including the part number or lot # was provided.The device history record could not be reviewed because the lot # information was not provided by the customer.Medical imaging was provided and analyzed.On (b)(6) 2015,an external reviewer reviewed the case imaging.The review contained the following findings: "1.A single cta of the chest abdomen and pelvis at aneurysm rupture is provided along with the complaint report.2.A type ia endoleak was present along the right lateral sealing stent.3.The neck aneurysm angulation was 68 degrees apex right anterior.4.The right seal zone was on the angulation's outer curvature.The seal zone along the right was 4mm long, much shorter than the left side owing to the greater neck length on the outer aortic curvature and lower positioning of the sealing stent on right.On the left, the neck length on the inner angulation's inner curvature was shorter.This required the sealing stent and suprarenal stents to telescope.This configuration was mentioned in the complaint report.Consequently, the severe angulation was not new but had been present since implantation.5.The sealing stent was ovoid due to the acute angulation and measured 24x29mm.The second mainbody stent was 27x32mm.The aortic wall thickness at the residual seal zone was normal despite dilation.6.The palmaz stent was round and uniformly cylindrical measuring 18.5mm in diameter.7.The aneurysm had ruptured and each limb seal zone overtaken by aneurysmal dilation that was impossible to separate from the extravasated blood except where it was calcified.Although no right limb type ib endoleak was imaged, the right limb seal zone was likely chronically compromised as calcified plaque marking right common iliac artery dilation was beyond the right limb sealing stent diameter.8.The left internal iliac artery and lumbar arteries had been embolized with coils and or glue.No type ii endoleak was imaged at rupture.9.The internal iliac arteries walls were aneurysmal or were surrounded by hematoma." additionally, the review noted the following impressions: "1.The original endograft was placed outside the ifu.First, the severe neck aneurysm angulation was likely present at implantation.Second the palmaz stent as a balloon expandable stent marked the original neck shape and diameter as cylindrical and approximately 20mm in lumen diameter.The endograft size was not provided but based on its measure diameter it was at least a tffb-30-96 and therefore oversized 33%.2.The original type ia endoleak was likely through pleating from excessive graft oversizing and hence the necessity to place a palmaz stent to 'iron out' the pleats.3.Loss of the proximal seal may have been secondary to type ii endoleak aneurysm growth as suggested in the complaint report however endotension from a compromised right limb seal was a possible.4.On the current scan, the left limb seal zone integrity cannot be determined as aneurysm and extravasated blood cannot be separated.If the seal zone is compromised, continued endotension is possible." the zenith device has completed design control requirements demonstrating that the device meets the predetermined requirements and that the requirements meet the needs of the user.Specifically, design verification testing included water permeability testing, migration resistance testing, and radial force testing.The results met the acceptance criteria.The ifu provides instructions for use, contraindications, warnings and precautions regarding the appropriate method of use.Specifically, it states "appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression." and "additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.Patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures." there is no evidence to suggest that the product was not manufactured to the correct specifications.The root cause for this complaint is that it appears that the ifu sizing instructions were not followed for proper endograft sizing.The graft appeared to be incorrectly oversized which led to other interventions, including the implanting of another manufacturer's balloon expandable stents.The appropriate internal personnel will be notified and we will continue to monitor for similar complaints.

Event Description

On (b)(6) 2012, a (b)(6) year old male patient underwent aaa repair.The main body was implanted 6mm distal from the renal artery due to adjustment gap of sealing stent and flex of proximal neck.After stent placement, proximal type i endoleak occurred, and another manufactures' stent was placed inside of the main body to treat endoleak.After placement of the other manufacturer's stent, no endoleak was confirmed.On an unknown date, enlargement of the aneurysm was confirmed due to type ii (from lumbar artery) and lumber artery embolization was performed.Sometime in (b)(6) 2015, enlargement of the aneurysm was confirmed due to proximal type i endoleak.On (b)(6) 2015, the patient complained about abdominal pains.Impending rupture was suspected and evar was performed urgently.The physician performed touch up ballooning to proximal neck; however, the endoleak would not resolve.Therefore, another manufacture's stent was implanted from just below renal artery.The amount of leakage was decreased, so the procedure completed.There have been no adverse effect to the patient reported.

• Brand Name: UNKNOWN
• 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: 4895913
• MDR Text Key: 6070656
• Report Number: 1820334-2015-00402
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 88 YR