N
Patient 1
THE IMPELLA CP IS CURRENTLY UNDER EVALUATION. THE MANUFACTURER WILL PROVIDE THE EVALUATION RESULTS AND CONCLUSIONS IN A SUPPLEMENTAL MEDWATCH REPORT UPON THE COMPLETION OF THE ANALYSIS.
MAUDE MDR 5652306
- MDR report key
- 5652306
- Report number
- 1220648-2016-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-04-13
- Date received
- 2016-05-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. WILLIAM BOLT
- Address
- ABIOMED, INC. 22 CHERRY HILL DRIVE DANVERS MA 01923 US
- Phone
- 978-978-9786
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMPELLA CP | TEMPORARY CARDIAC SUPPORT BLOOD PUMP | ABIOMED EUROPE, GMBH (GERMANY) | PBL | IMPELLA CP | 0048-0003 | 1226951 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-05-13 | 0 | 1. R |
Event Narratives#
D
Patient 1
THE COMPLAINANT REPORTED THAT THEY WERE TREATING A (B)(6) MALE PATIENT ON POSTOPERATIVE DAY 1, AFTER HAVING RECEIVED 4 BYPASS GRAFTS. THE PATIENT WAS PRESENTING WITH WORSENING CARDIOGENIC SHOCK, DESPITE HAVING MULTIPLE DRIPS AND THE PLACEMENT OF AN INTRA-AORTIC BALLOON PUMP (IABP.) THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LABORATORY (CATH LAB) TO HAVE THE IABP REPLACED WITH AN IMPELLA CP. DURING THE IMPELLA CP PLACEMENT IN THE LEFT FEMORAL ARTERY THE SHEATH WAS PLACED WITHOUT ISSUE. THE PUMP WAS INSERTED AND AUTO-FLOW WAS SUCCESSFULLY INITIATED. THE SHEATH WAS REMOVED, AND THE REPOSITIONING SHEATH WAS ADVANCED; HOWEVER, THE PHYSICIAN WAS UNABLE TO FULLY ADVANCE THE REPOSITIONING SHEATH. WHILE HOLDING PRESSURE, THE REPOSITIONING SHEATH WAS REMOVED AND ASSESSED. IT WAS REPORTED THAT A SMALL LONGITUDINAL TEAR NEAR THE DISTAL END OF THE SHEATH WAS SEEN, AND WAS BELIEVED TO HAVE PREVENTED THE REPOSITIONING SHEATH'S ADVANCEMENT. MANUAL PRESSURE WAS HELD TO THE IMPELLA'S 9 FRENCH CATHETER. AN ANGIOGRAM OF THE LEFT GROIN WAS PERFORMED, WHICH REVEALED EXTRAVASATION AROUND THE SITE. THE PHYSICIAN PLACED A COVERED STENT FOR HEMOSTASIS. AS THE COVERED STENT DEPLOYMENT SYSTEM WAS ADVANCED FROM CONTRALATERAL SIDE, THE IMPELLA TO LFA WAS REMOVED. THE COVERED STENT WAS DEPLOYED TO THE LFA WITH GOOD RESULTS. THE REPLACEMENT IMPELLA CP WAS PREPPED AND PLACED IN THE PATIENT VIA THE RIGHT FEMORAL ARTERY, AND AUTO FLOW WAS INITIATED. THE SHEATH WAS LEFT IN PLACE AND THE REPOSITIONING SHEATH WAS SUCCESSFULLY ADVANCED THROUGH THE SHEATH. THE PATIENT WAS REPORTED TO HAVE REQUIRED 2 UNITS OF REPLACEMENT BLOOD PRODUCTS. THE PATIENT WAS SUCCESSFULLY SUPPORTED WITH THE REPLACEMENT IMPELLA CP FOR APPROXIMATELY 7 HOURS, WHEN THE PATIENT CODED, AND THE FAMILY WITHDREW CARE. THE PATIENT OUTCOME WAS REPORTED NOT TO HAVE BEEN THE RESULT OF ANY ISSUE THAT OCCURRED WITH THE FIRST IMPELLA.
N
Patient 1
THE IMPELLA CP WAS RETURNED FOR EVALUATION. AN INSPECTION OF THE REPOSITIONING SHEATH REVEALED THAT THE WOUND CLOSURE DEVICE HAD BEEN BADLY DAMAGED, AND THAT THE TIP OF THE SHEATH HAD BEEN CUT OFF. THE TEAR IN THE WOUND CLOSURE APPEARED TO START IN AN AREA WHERE A ROUTINE REWORK IS PERFORMED DURING THE MANUFACTURING PROCESS. FLASH REMOVAL MAY WEAKEN THE SHEATH AT THIS POING AND IF THE SHEATH ENCOUNTERS RESISTANCE DURING INSERTION, THEN THESE SMALL TEARS MAY ACT AS INITIATION POINTS FOR A LARGER TEAR. BECAUSE THE TIP OF THE SHEATH HAD BEEN CUT OFF, IT WAS IMPOSSIBLE TO DETERMINE THE EXACT ORIGIN OF THE TEAR; HOWEVER, IT APPEARED THAT THE TEAR MAY HAVE ORIGINATED IN AN AREA WHERE THE ROUTINE REWORK IS DONE DURING THE MANUFACTURING PROCESS. IF THE SHEATH ENCOUNTERS RESISTANCE DURING INSERTION, THEN THESE SMALL TEARS CAN ACT AS INITIATION POINTS FOR A LARGER TEAR. THE ROOT CAUSE OF THE DAMAGED REPOSITIONING SHEATH WAS MOST LIKELY A COMBINATION OF THE PATIENT CONDITION AND THE MANUFACTURING PROCESS. SMALL TEARS IN THE WOUND CLOSURE AS A RESULT OF FLASH REMOVAL DURING MANUFACTURING CONTRIBUTED TO A LARGER TEAR IN THE WOUND CLOSURE. IN ADDITION, THE LARGER TEAR MAY HAVE BEEN DUE TO CONTACT WITH A RIGID STRUCTURE (E.G. CALCIFICATION) DURING INSERTION OF THE REPOSITIONING SHEATH. A CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS REPOSITIONING SHEATH FAILURE. INTERNAL REFERENCE: (B)(4).