TREO ABDOMINAL STENT-GRAFT SYSTEM
Report
- Report Number
- 2247858-2020-00029
- Event Type
- Malfunction
- Date Received
- June 2, 2020
- Date of Event
- May 6, 2020
- Report Date
- July 31, 2020
- Manufacturer
- BOLTON MEDICAL, INC.
- Product Code
- MIH
- PMA / PMN Number
- P190015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THE TREO ABDOMICAL STENT GRAFT SYSTEM RECEIVED FDA APPROVAL FOR SALE IN THE US ON MAY 4, 2020 (P190015).
"DURING THE IMPLANTATION OF THE TREO STENT, AT THE TIME OF RELEASE THE PROXIMAL CLASP, WHEN THE DOCTOR DID THE PUSH AND TURN THE GRAY KNOB, HE WAS UNABLE TURN IT AND TRIED TO TURN IT A SECOND TIME TO THE OPPOSITE SIDE AND IT WORKED. BUT WHEN HE HAD TO ASSEMBLE THE BLACK CLASP ON THE GRAY, IT DIDN'T ADVANCE AND WAS BLOCKED, OBVIOUSLY CAUSING THE IMPOSSIBILITY TO RELEASE THE SUPRARENAL STENT. THEY THEN HAD TO PERFORM THE MANEUVER TO OPEN THE RAIL THROUGH WHICH THE GREEN CABLE RUNS AND PULL IT WITH A KOCHER AND MANUALLY OPEN THE PROXIMAL CLASP. THE SUPRARENAL STENT WAS THEN DETACHED, AND THE PROSTHESIS WAS FIXED CORRECTLY. THE MANIPULATION TO RELEASE MANUALLY THE PROXIMAL STENT CAUSED THE RUPTURE OF THE DISTAL PART OF THE DELIVERY SYSTEM, RUPTURE OF THE GUIDEWIRE AND THE RISK THAT ALL THIS ABRUPT MANIPULATION OF THE PATIENT ENTAILS. WHEN THE PROCEDURE WAS FINISHED, THE PHYSICIAN OPENED THE RELEASE SYSTEM TO STUDY WHAT MIGHT BE THE ROOT CAUSE OF PROBLEM IN THE PART OF THE CLASP RELEASE AND THE DISTAL PART OF THE RELEASE SYSTEM, NOTING THAT THE GREEN CABLE HAD NO SPACE TO DROP ONTO THE RAIL. IN OPINION OF THIS CUSTOMER IT'S A "MANUFACTURING FAILURE" OR INSUFFICIENT SPACE FOR THE CABLE PULLING THE PROXIMAL CLASP TO BULGE AND RELEASE THE STENT. LAST BUT NOR LEAST, THIS DOCTOR WHO HAD USED APPROXIMATELY 15 TREO ENDOGRAFTS HAS FACED THE SAME PROBLEM FOR A SECOND TIME AND IS CLAIMING FOR A SUFFICIENT ANSWER AND MOST IMPORTANT A SOLUTION FOR THIS RECURRING EVENT. " PATIENT OUTCOME: "N/A".
THE TREO ABDOMICAL STENT GRAFT SYSTEM RECEIVED FDA APPROVAL FOR SALE IN THE US ON MAY 4, 2020 (P190015).
"DURING THE IMPLANTATION OF THE TREO STENT, AT THE TIME OF RELEASE THE PROXIMAL CLASP, WHEN THE DOCTOR DID THE PUSH AND TURN THE GRAY KNOB, HE WAS UNABLE TURN IT AND TRIED TO TURN IT A SECOND TIME TO THE OPPOSITE SIDE AND IT WORKED. BUT WHEN HE HAD TO ASSEMBLE THE BLACK CLASP ON THE GRAY, IT DIDN'T ADVANCE AND WAS BLOCKED, OBVIOUSLY CAUSING THE IMPOSSIBILITY TO RELEASE THE SUPRARENAL STENT. THEY THEN HAD TO PERFORM THE MANEUVER TO OPEN THE RAIL THROUGH WHICH THE GREEN CABLE RUNS AND PULL IT WITH A KOCHER AND MANUALLY OPEN THE PROXIMAL CLASP. THE SUPRARENAL STENT WAS THEN DETACHED, AND THE PROSTHESIS WAS FIXED CORRECTLY. THE MANIPULATION TO RELEASE MANUALLY THE PROXIMAL STENT CAUSED THE RUPTURE OF THE DISTAL PART OF THE DELIVERY SYSTEM, RUPTURE OF THE GUIDEWIRE AND THE RISK THAT ALL THIS ABRUPT MANIPULATION OF THE PATIENT ENTAILS. WHEN THE PROCEDURE WAS FINISHED, THE PHYSICIAN OPENED THE RELEASE SYSTEM TO STUDY WHAT MIGHT BE THE ROOT CAUSE OF PROBLEM IN THE PART OF THE CLASP RELEASE AND THE DISTAL PART OF THE RELEASE SYSTEM, NOTING THAT THE GREEN CABLE HAD NO SPACE TO DROP ONTO THE RAIL. IN OPINION OF THIS CUSTOMER IT'S A "MANUFACTURING FAILURE" OR INSUFFICIENT SPACE FOR THE CABLE PULLING THE PROXIMAL CLASP TO BULGE AND RELEASE THE STENT. LAST BUT NOR LEAST, THIS DOCTOR WHO HAD USED APPROXIMATELY 15 TREO ENDOGRAFTS HAS FACED THE SAME PROBLEM FOR A SECOND TIME AND IS CLAIMING FOR A SUFFICIENT ANSWER AND MOST IMPORTANT A SOLUTION FOR THIS RECURRING EVENT. " PATIENT OUTCOME: "N/A".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 571357 | TREO ABDOMINAL STENT-GRAFT SYSTEM | STENT, ENDOVASCUALR GRAFT, AORTIC | MIH | BOLTON MEDICAL, INC. | B200116190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00 YR |