MAUDE Adverse Event Report: MEDTRONIC-SUNNYVALE/APTUS ENDOSYSTEMS ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number SA-85

Device Problems Difficult to Insert (1316); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

An endurant ii stent graft and an aptus heli-fx endosystem was used for endovascular treatment.The diameter of aorta at the level of the renal artery measured 32 mm.The length of the proximal aortic neck measured 20 mm.The proximal aortic neck was angulated 75 degrees.The vessel was tortuous.There was no vessel calcification.It was reported that during the index procedure the plan was to prophylactically implant the endoanchors.However, due to the patients anatomy, specifically a short, angulated and conical neck, a type i endoleak was seen on the right side after the endurant graft deployment.Six endoanchors were successfully implanted.At that point the guide sheath could no longer be used be used due to trouble advancing the applier through the sheath.The device was examined on the table top and the applier did go through outside the patient.The device was put back into the patient and another endoanchor was implanted.After deployment there was trouble with the guide sheath.It would not deflect.It was noted that this was tried both inside and outside the patient and it would not deflect in either environment.As a result, no additional endoanchors could be implanted.The type i endoleak was not resolved and it was noted that the patient may require additional endoanchors.Per the physician, the cause of the event was unknown.No additional clinical sequelae were reported and the patient is being monitored by the physician.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the patient had a one month follow up ct and the type ia endoleak had not resolved.An intervention was performed and (b)(6) additional endoanchors were implanted.No endoleak was identified on the intra-operative arteriogram.A week later a final angiogram appeared to show that the endoleak was gone.The patient reportedly recovered well and was sent home the next day.

Manufacturer Narrative

Corrected information: sex, date of birth.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-SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC-SUNNYVALE/APTUS ENDOSYSTEMS; 271 gibraltar dr; sunnyvale CA 94089
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5540109
• MDR Text Key: 41669124
• Report Number: 2953200-2016-00694
• Device Sequence Number: 1
• Product Code: OTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/14/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 49487056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/14/2016
• Supplement Dates FDA Received: 04/08/2016; 04/25/2016; 09/20/2017
• Date Device Manufactured: 09/15/2015
• 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: 00069 YR