MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number SA-85

Device Problems Break (1069); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2013

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A heli-fx system was used as an accessory device along with an endurant stent graft for an unknown endovascular treatment.During the index procedure, it was reported that the main body of the endurant stent graft was deployed lower than anticipated and a type ia endoleak was observed.Seven endoanchors were implanted to the proximal neck area of the endograft, the first endoanchor did not properly penetrate the aortic wall and was reportedly broken/fractured.It was reported that there was still a persistent type ia endoleak and it was determined that an aortic extension was necessary and an endurant cuff was implanted to resolve the type ia endoleak.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

Film evaluation summary: the exact cause of the events could not be determined from the returned films.Review of pre-implant ct¿s revealed that the patient had a 67mm max diameter infrarenal aaa.The proximal neck was conical-shaped ranging from 18 ¿ 26 ¿ 28mm along the 15mm length neck.The neck was severely angulated measuring ~65 deg lt-rt x 55 deg a-p, and the suprarenal neck was also angulated ~55 deg rt-lt.Returned angiograms during implant confirmed that the endurant bifurcate was deployed ~5mm below the left renal artery.Contrast injection from above the renals showed widespread contrast within the proximal neck, primarily along the left/outer stent graft curvature, from a likely proximal type i endoleak.Multiple endo anchors were then seen having been implanted into the proximal portion of the bifurcate and severely angulated aorta; images during implant were not seen in the films.The 1st anchor was implanted near the proximal margin along the right (outer) wall.The next anchor was seen implanted ~5mm distally and directly below the 1st, and that 2nd anchor appeared to have fractured into 2 sections.Several additional anchors were then seen implanted around the remaining perimeter of the proximal bifurcate; no other obvious issues were observed.Angio injection was then performed with contrast of similar strength was again seen from a likely proximal type i endoleak, and an endurant aortic cuff was then seen implanted ~5mm above the bifurcate.After ballooning, final angiogram showed a slight amount of contrast within the proximal sac, likely from a residual type ia and/or type iv endoleak.The possible cause of the low placement of the bifurcate, which likely contributed to the type i endoleak, was most likely the severely angulated and conical-shaped proximal neck.The challenging neck anatomy may have also contributed to the fractured endoanchor; however, a procedural/use issue may have also been a factor.A device issue cannot be ruled out as a potential cause.However, the delivery system was not returned and the product investigation could not be performed.The cause of the aaa expansion also could not be determined.Ct¿s returned from 1 ¿ 4 years post-implant showed continuous aaa diameter enlargement from 67 ¿ 89 mm.Lack of contrast did not allow for assessment of any possible endoleak; however, there appeared to be disease progression of the neck with associated diameter enlargement and reduced proximal sealing length which may have contributed to a potential type i endoleak.Other than the single fractured endoanchor occurring during implant, no interval changes in the in-vivo configuration of the implanted stent graft system, or additional issues with the endoanchors, were seen during the follow-up¿s, and it is therefore unlikely that the fractured anchor was a primary cause of the aaa expansion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Type of Device: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7463731
• MDR Text Key: 106583357
• Report Number: 2953200-2018-00619
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82