SYNERGY MEGATRON
Report
- Report Number
- 2134265-2021-02495
- Event Type
- Death
- Date Received
- March 1, 2021
- Date of Event
- February 24, 2021
- Report Date
- April 21, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
LOT NUMBER UPDATED FROM UNKNOWN TO 0025420655 :EXPIRATION DATE UPDATED FROM UNKNOWN TO 03/09/2022 :UNIQUE IDENTIFIER (UDI) : UPDATED FROM UNKNOWN TO (B)(4). DEVICE MANUFACTURE DATE UPDATED FROM UNKNOWN TO 03/09/2020 SUMMARY OF MEDIA REVIEW: PROCEDURAL ANGIOGRAPHIC MEDIA WAS PROVIDED TO ASSIST IN THE INVESTIGATION AND WAS REVIEWED BY A BOSTON SCIENTIFIC MEDICAL DIRECTOR. THE PROVIDED ANGIOGRAPHIC MEDIA IS CONSISTENT WITH THE CATHETER DIFFICULT TO REMOVE EVENT. THE PATIENT ANATOMY WAS A FEMORAL APPROACH, SUPER-DOMINANT RIGHT CORONARY ARTERY. LARGE, DIFFUSELY DISEASED AND CALCIFIED TARGET VESSEL WAS OBSERVED. AFTER PRE-DILATION A LARGE STENT WAS IMPLANTED AND EXPANDED ABOVE MAXIMUM RECOMMENDED PRESSURE. SUBSEQUENT IMAGING REVELED LARGE AMOUNT OF CONTRAST EXTRAVASATION CONSISTENT WITH CORONARY RUPTURE AT THE STENTED SEGMENT. VESSEL OCCLUSION TO CONTROL BLEEDING THROUGH THE STENT WAS PERFORMED WITH THE SDS BALLOON. DIFFICULTY WITHDRAWING THE SDS LED TO AGGRESSIVE MANEUVERS TO WITHDRAW THE SDS FOLLOWED BY DEVICE SEPARATION. COVERED STENT IMPLANTATION WAS NOT POSSIBLE BECAUSE THE SDS FRAGMENT REMAINED AT THE LESION SITE. A LARGER BALLOON WAS USED TO OCCLUDE THE VESSEL TO CONTROL BLEEDING INTO THE PERICARDIAL SPACE; HOWEVER THE OCCLUSION ALSO PREVENTED BLOOD FLOW TO THE DISTAL VESSEL CAUSING SIGNIFICANT MYOCARDIAL ISCHEMIA. LARGE VESSEL ACCESS FOR MECHANICAL CIRCULATORY SUPPORT WAS COMPROMISED BY SIGNIFICANT LEFT ILIOFEMORAL ARTERY DISEASE.THE PATIENT SUBSEQUENTLY EXPIRED DUE TO MYOCARDIAL ISCHEMIA. DEVICE TECHNICAL ANALYSIS: A SYNERGY MEGATRON MR OUS 5.00 X 16MM CATHETER WAS RETURNED FOR ANALYSIS BROKEN IN TWO PIECES WITHOUT THE DISTAL SHAFT (FROM PORT EXCHANGE DISTAL INNER AND OUTER, BALLOON, STENT AND TIP MISSING). A PARTIAL DEVICE WAS RETURNED BROKEN IN 2 PIECES WITHOUT THE DISTAL SHAFT (INCLUDING PORT EXCHANGE DISTAL INNER AND OUTER, BALLOON, STENT AND TIP). THE LENGTH OF THE DEVICE FROM THE PROXIMAL TIP OF THE MANIFOLD TO THE HYPOTUBE BREAK SITE WAS 34.8CM. THE SECOND SECTION OF THE DEVICE MEASURED 91.5CM IN LENGTH FROM THE HYPOTUBE BREAK SITE TO THE HYPOTUBE TAB WITH THE SHAFT POLYMER EXTRUSION AND CORE WIRE EXPOSED. A VISUAL AND TACTILE EXAMINATION OF THE HYPOTUBE SHAFT FOUND A BREAK 34.8CM FROM THE PROXIMAL TIP OF THE MANIFOLD TO THE HYPOTUBE BREAK SITE AND MULTIPLE KINKS ALONG THE LENGTH OF THE SHAFT. BLOOD LIKE SUBSTANCE WAS VISIBLE WITH NO HYPOTUBE. A VISUAL EXAMINATION OF THE MID-SHAFT SECTION IDENTIFIED A MISSING DISTAL SHAFT WITH THE LUMEN/SHAFT POLYMER EXTRUSION BREAK 3CM DISTAL TO HYPOTUBE TAB AND CORE WIRE EXPOSED AND KINKED. BLOOD LIKE SUBSTANCE WAS VISIBLE IN SHAFT POLYMER EXTRUSION AND HYPOTUBE TAB. MID SHAFT BOND LUMEN DAMAGE WAS NOTED. MID SHAFT BOND BULGE OUTER DIAMETER WAS MEASURED FOR REFERENCE. A VISUAL AND TACTILE EXAMINATION OF THE HUB/MANIFOLD FOUND NO ISSUES. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
D3: LOT NUMBER UPDATED FROM UNKNOWN TO 0025420655. D3:EXPIRATION DATE UPDATED FROM UNKNOWN TO 03/09/2022. D3:UNIQUE IDENTIFIER (UDI) : UPDATED FROM UNKNOWN TO (B)(4). H4: DEVICE MANUFACTURE DATE UPDATED FROM UNKNOWN TO 03/09/2020.
IT WAS REPORTED THAT A DEATH OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 16MM X 5MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS IMPLANTED AT 20 ATMOSPHERES AND A MAJOR CORONARY ARTERY RUPTURE OCCURRED. THE CATHETER WAS UNABLE TO BE REMOVED FROM THE PATIENT. FORCE WAS APPLIED TO REMOVE IT AND THE SHAFT OF THE CATHETER BROKE IN TWO PLACES AT THE DISTAL MONORAIL PART AND THE HYPOTUBE PART. IT WAS NOT POSSIBLE TO PLACE A COVERED STENT AS THE BALLOON REMAINED IN THE CORONARY ARTERY. THE PATIENT WAS ISCHEMIC AND HYPOTENSIVE FOR APPROXIMATELY 90 MINUTES AND DIED SHORTLY AFTER THE END OF THE PROCEDURE.
IT WAS REPORTED THAT A DEATH OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 16MM X 5MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS IMPLANTED AT 20 ATMOSPHERES AND A MAJOR CORONARY ARTERY RUPTURE OCCURRED. THE CATHETER WAS UNABLE TO BE REMOVED FROM THE PATIENT. FORCE WAS APPLIED TO REMOVE IT AND THE SHAFT OF THE CATHETER BROKE IN TWO PLACES AT THE DISTAL MONORAIL PART AND THE HYPOTUBE PART. IT WAS NOT POSSIBLE TO PLACE A COVERED STENT AS THE BALLOON REMAINED IN THE CORONARY ARTERY. THE PATIENT WAS ISCHEMIC AND HYPOTENSIVE FOR APPROXIMATELY 90 MINUTES AND DIED SHORTLY AFTER THE END OF THE PROCEDURE.
IT WAS REPORTED THAT A DEATH OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 16 MM X 5 MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS IMPLANTED AT 20 ATMOSPHERES AND A MAJOR CORONARY ARTERY RUPTURE OCCURRED. THE CATHETER WAS UNABLE TO BE REMOVED FROM THE PATIENT. FORCE WAS APPLIED TO REMOVE IT AND THE SHAFT OF THE CATHETER BROKE IN TWO PLACES AT THE DISTAL MONORAIL PART AND THE HYPOTUBE PART. IT WAS NOT POSSIBLE TO PLACE A COVERED STENT AS THE BALLOON REMAINED IN THE CORONARY ARTERY. THE PATIENT WAS ISCHEMIC AND HYPOTENSIVE FOR APPROXIMATELY 90 MINUTES AND DIED SHORTLY AFTER THE END OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290173 | SYNERGY MEGATRON | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC CORPORATION | 0025420655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |