RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Report
- Report Number
- 2247858-2020-00043
- Event Type
- Death
- Date Received
- September 25, 2020
- Date of Event
- August 31, 2020
- Report Date
- October 28, 2020
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P110038
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
"SURGEON FIRST ATTEMPTED TO TREAT THIS THORACIC AORTIC DISSECTION WITH A MEDTRONIC NAVION DEVICE. THE DEVICE DID NOT ACHIEVE THE PHYSICIAN'S DESIRED POSITION, SO HE WITHDREW THE FIRST NAVION AND ATTEMPTED TO INSERT A SECOND ONE. WHEN THE SECOND ONE DID NOT ACHIEVE ITS DESIRED POSITION, HE THEN CHOSE TO TRY A RELAY PLUS 36X150 STRAIGHT. THE SURGEON INTRODUCED THIS DEVICE INTO THE FEMORAL ARTERY VIA PERCUTANEOUS APPROACH. THE DELIVERY SYSTEM NAVIGATED INTO PROXIMAL DESCENDING THORACIC AORTA OVER A 300CM DOUBLE CURVED LUNDERQUIST WIRE WITHOUT INCIDENT. IN POSITION 1 SURGEON BEGAN TO ADVANCE DEVICE BY ADVANCING GREY HANDLE. WHEN DEVICE WAS APPROXIMATELY HALF WAY OUT OF PRIMARY SHEATH THE PHYSICIAN VOICED THAT HE FELT RESISTANCE. HE ATTEMPTED TO WITHDRAW THE DEVICE AS ONE UNIT BUT COULDN'T, NOR COULD HE ADVANCE THE ENTIRE SYSTEM EITHER, SO HE CONTINUED TO ADVANCE THE DEVICE THROUGH THE "RESISTANCE" IN POSITION 1 BY ADVANCING THE GREY HANDLE. AS HE DID, THE DEVICE BEGAN TO EXPAND AT THE PROXIMAL PORTION. IT APPEARED AS THOUGH THE BARE METAL STENT AND THE FIRST FABRIC COVERED STENT HAD BOTH BECOME EXPOSED. AT THIS POINT THE PHYSICIAN COULD NOT ADVANCE THE DEVICE AS A WHOLE TO MOVE IT INTO THE INTENDED DEPLOYMENT LOCATION, SO HE DEPLOYED THE DEVICE AT IT'S CURRENT LOCATION IN THE PROXIMAL DESCENDING AORTA BY USING THE REVERSE DEPLOYMENT TECHNIQUE WHILE STILL IN POSITION 1. HE THEN SWITCHED TO POSITION 2 AND ATTEMPTED TO FULLY WITHDRAW THE CONSTRAINING SLEEVE BY COMPLETELY WITHDRAWING THE GREY HANDLE, FOLLOWED BY THE RELEASE OF THE CLASPING MECHANISM VIA REMOVING THE THUMB SCREW AND WITHDRAWING THE CLASP IN POSITION 3. IT APPEARED THAT AFTER THIS STEP THE DEVICE DID NOT COMPLETELY EXPAND IN THE DISTAL ASPECT, SO INSTEAD OF SWITCHING TO POSITION 4 AND RECAPTURING, THE PHYSICIAN WITHDREW THE ENTIRE DELIVERY SYSTEM AS A WHOLE UNTIL THE PROXIMAL TIP WAS DISTAL TO THE DEVICE. HE THEN SWITCHED TO POSITION 4, RECAPTURED AND WITHDREW THE DEVICE FROM THE PATIENT. THE ENDOGRAFT REMAINED IMPLANTED IN THE PROXIMAL THORACIC AORTA. AFTER THE RELAY PLUS DEVICE WAS DEPLOYED THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 37X150 GORE CTAG THAT ALSO DID NOT REACH THE DESIRED IMPLANT LOCATION. THE PHYSICIAN THEN ATTEMPTED TO COVER THE PROXIMAL ENTRY TEARS BY DEPLOYING THE CTAG DEVICE DISTAL TO ITS INTENDED LANDING ZONE BUT INTRA OPERATIVE ANGIOGRAPHY REVEALED A PERSISTENT PRESENCE OF CONTRAST IN THE FALSE LUMEN POST DEPLOYMENT. AS THEY WERE DETERMINING HOW/WHETHER TO PROCEED WITH A DIFFERENT SOLUTION THE PATIENT BECAME HYPOTENSIVE AND PASSED AWAY IN THE OPERATING ROOM. " PATIENT OUTCOME: "THE PATIENT BECAME HYPOTENSIVE AND EXPIRED, PRESUMABLY (ACCORDING TO THE SURGEON) BECAUSE OF A RUPTURE TO THE THORACIC AORTA."
"SURGEON FIRST ATTEMPTED TO TREAT THIS THORACIC AORTIC DISSECTION WITH A MEDTRONIC NAVION DEVICE. THE DEVICE DID NOT ACHIEVE THE PHYSICIAN'S DESIRED POSITION, SO HE WITHDREW THE FIRST NAVION AND ATTEMPTED TO INSERT A SECOND ONE. WHEN THE SECOND ONE DID NOT ACHIEVE ITS DESIRED POSITION, HE THEN CHOSE TO TRY A RELAY PLUS 36X150 STRAIGHT. THE SURGEON INTRODUCED THIS DEVICE INTO THE FEMORAL ARTERY VIA PERCUTANEOUS APPROACH. THE DELIVERY SYSTEM NAVIGATED INTO PROXIMAL DESCENDING THORACIC AORTA OVER A 300CM DOUBLE CURVED LUNDERQUIST WIRE WITHOUT INCIDENT. IN POSITION 1 SURGEON BEGAN TO ADVANCE DEVICE BY ADVANCING GREY HANDLE. WHEN DEVICE WAS APPROXIMATELY HALF WAY OUT OF PRIMARY SHEATH THE PHYSICIAN VOICED THAT HE FELT RESISTANCE. HE ATTEMPTED TO WITHDRAW THE DEVICE AS ONE UNIT BUT COULDN'T, NOR COULD HE ADVANCE THE ENTIRE SYSTEM EITHER, SO HE CONTINUED TO ADVANCE THE DEVICE THROUGH THE "RESISTANCE" IN POSITION 1 BY ADVANCING THE GREY HANDLE. AS HE DID, THE DEVICE BEGAN TO EXPAND AT THE PROXIMAL PORTION. IT APPEARED AS THOUGH THE BARE METAL STENT AND THE FIRST FABRIC COVERED STENT HAD BOTH BECOME EXPOSED. AT THIS POINT THE PHYSICIAN COULD NOT ADVANCE THE DEVICE AS A WHOLE TO MOVE IT INTO THE INTENDED DEPLOYMENT LOCATION, SO HE DEPLOYED THE DEVICE AT IT'S CURRENT LOCATION IN THE PROXIMAL DESCENDING AORTA BY USING THE REVERSE DEPLOYMENT TECHNIQUE WHILE STILL IN POSITION 1. HE THEN SWITCHED TO POSITION 2 AND ATTEMPTED TO FULLY WITHDRAW THE CONSTRAINING SLEEVE BY COMPLETELY WITHDRAWING THE GREY HANDLE, FOLLOWED BY THE RELEASE OF THE CLASPING MECHANISM VIA REMOVING THE THUMB SCREW AND WITHDRAWING THE CLASP IN POSITION 3. IT APPEARED THAT AFTER THIS STEP THE DEVICE DID NOT COMPLETELY EXPAND IN THE DISTAL ASPECT, SO INSTEAD OF SWITCHING TO POSITION 4 AND RECAPTURING, THE PHYSICIAN WITHDREW THE ENTIRE DELIVERY SYSTEM AS A WHOLE UNTIL THE PROXIMAL TIP WAS DISTAL TO THE DEVICE. HE THEN SWITCHED TO POSITION 4, RECAPTURED AND WITHDREW THE DEVICE FROM THE PATIENT. THE ENDOGRAFT REMAINED IMPLANTED IN THE PROXIMAL THORACIC AORTA. AFTER THE RELAY PLUS DEVICE WAS DEPLOYED THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A 37X150 GORE CTAG THAT ALSO DID NOT REACH THE DESIRED IMPLANT LOCATION. THE PHYSICIAN THEN ATTEMPTED TO COVER THE PROXIMAL ENTRY TEARS BY DEPLOYING THE CTAG DEVICE DISTAL TO ITS INTENDED LANDING ZONE BUT INTRA OPERATIVE ANGIOGRAPHY REVEALED A PERSISTENT PRESENCE OF CONTRAST IN THE FALSE LUMEN POST DEPLOYMENT. AS THEY WERE DETERMINING HOW/WHETHER TO PROCEED WITH A DIFFERENT SOLUTION THE PATIENT BECAME HYPOTENSIVE AND PASSED AWAY IN THE OPERATING ROOM. " PATIENT OUTCOME: "THE PATIENT BECAME HYPOTENSIVE AND EXPIRED, PRESUMABLY (ACCORDING TO THE SURGEON) BECAUSE OF A RUPTURE TO THE THORACIC AORTA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1050763 | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM | STENT, ENDOVASCUALR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | 180917158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |