FDA Adverse Event Malfunction Summary report: N

APTUS HELI-FX ENDOANCHOR SYSTEM

MDR report key: 6521930 · Received April 26, 2017

Report

Report Number
6521930
Event Type
Malfunction
Date Received
April 26, 2017
Date of Event
April 6, 2017
Report Date
April 7, 2017
Manufacturer
MEDTRONIC VASCULAR, INC.
Product Code
OTD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
VA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PERCUTANEOUS ENDOGRAFT, STENTS PLACED IN AORTA, USED MEDTRONIC (B)(6) DEVICE TO PLACE ANCHORS IN STENTS IN THE AORTA. THREE ANCHORS WERE DEPLOYED AND ONE ANCHOR CRACKED/FRACTURED IN HALF. SURGEON WAS ABLE TO SECURE A PORTION OF THE ANCHOR, ATTEMPTED FOR 60 MINS TO REMOVE THE PORTION OF THE ANCHOR IN AORTA WITH SUPPLIES FROM CATH LAB, INCLUDING FORCEPS, ENSNARES, ETC. SURGEON WAS UNABLE TO GET A GRIP ON THE PIECE OF (B)(6) AND DECIDED TO PUSH IT INTO THE AORTIC WALL AND LEAVE IT. THE PATIENT WAS UNDER MONITORED ANESTHESIA CARE. NO ADDITIONAL BLOOD LOSS. ADDED APPROXIMATELY 60 MINS TO THE CASE WHERE DOCTOR ATTEMPTED TO GRASP AND REMOVE THE PIECE OF ANCHOR. THE PORTION THAT WAS REMOVED WAS SECURED AND WILL BE SENT ALONG WITH THE APPLIERS AND INFORMATION TO QUALITY DEPT. FOR INVESTIGATION. PAPERWORK AND DEVICES GIVEN TO QUALITY DEPT. CHART REVIEW: COMPLICATIONS FROM BRIEF OP NOTE: FRACTURED ENDOANCHOR WITH RETRIEVAL OF HALF AND INTENTIONAL EMBEDDING OF REMAINING PORTION OF ENDOANCHOR IN POSTERIOR WALL OF AORTA. PROCEDURAL NOTE: NEXT, DUE TO THE ANTERIOR POSTERIOR AND RIGHT TO LEFT ANGULATION IT WAS FELT THAT IT WOULD BE BEST TO ACTIVELY FIXATE THE PROXIMAL LANDING ZONE USING (B)(6) ENDO-ANCHORS. THREE ENDO-ANCHORS WERE PLACED AND WITH ATTEMPTED PLACEMENT OF THE FOURTH ENDO ANCHOR IT WAS NOTED THAT THE ENDOANCHOR FRACTURED. THE LARGEST PORTION OF THE FRACTURED ENDO-ANCHOR REMAINED WITHIN THE GRAFT MATERIAL. THIS WAS ABLE TO BE SNARED WITH AN END SNARE AND REMOVED USING THE (B)(6) CONFORMABLE SHEATH. NEXT, ATTENTION WAS TURNED TO REMOVAL OF THE SMALL ENDO-ANCHOR FRAGMENT, WHICH WAS ALONG THE POSTERIOR ASPECT OF THE ENDOGRAFT. DESPITE MULTIPLE ATTEMPTS WITH GOOSENECK SNARE, AND SNARE AND GRASPING FORCEPS, THE SMALL FRAGMENT OF ENDO-ANCHOR WAS UNABLE TO BE RETRIEVED. IT WAS, HOWEVER, ABLE TO BE MANEUVERED INTO A SUPRARENAL LOCATION WHERE THERE WAS KNOWN TO BE A SIGNIFICANT AMOUNT OF SOFT INTRAMURAL THROMBUS WITHIN THE POSTERIOR WALL OF THE AORTA. THEREFORE A DECISION WAS MADE TO GENTLY BALLOON DILATE THIS AREA OVER THE ENDO ANCHOR AND EMBEDDED WITHIN THE SOFT INTRAMURAL THROMBUS. THIS WAS SUCCESSFULLY ACHIEVED USING THE RELIANT BALLOON. NEXT, THE PROXIMAL AND DISTAL SEALS ZONES AS WELL AS ALL OVERLAPPING ZONES WERE BALLOON MOLDED USING THE SAME RELIANT BALLOON. COMPLETION AORTOGRAM WAS OBTAINED WHICH REVEALED SUCCESSFUL EXCLUSION OF THE ABDOMINAL AORTIC ANEURYSM WITH NO EVIDENCE OF ENDOLEAK. NO HARM, DISCHARGED DAY AFTER SURGERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
303549 APTUS HELI-FX ENDOANCHOR SYSTEM ENDOVASCULAR SUTURING SYSTEM OTD MEDTRONIC VASCULAR, INC. SG-64

Patients

Seq Age Sex Outcome Treatment
1 86 YR (B)(6 HELI-FX ENDOANCHOR SYSTEM GUIDE 22MM, REF# S| NOT APPLICABLE.