IMPELLA RP US HDE PUMP SET
Report
- Report Number
- 1220648-2016-00036
- Event Type
- Injury
- Date Received
- November 22, 2016
- Date of Event
- September 29, 2016
- Report Date
- September 29, 2016
- Manufacturer
- ABIOMED, INC
- Product Code
- OJE
- PMA / PMN Number
- H140001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
THIS SUPPLEMENTAL REPORT WAS ORIGINALLY REPORTED ON MISLABELED MEDWATCH REPORT 1220648-2016-00026-01. THIS REPORT IS BEING SUBMITTED TO REPORT THE INFORMATION ON A CORRECTLY LABELED SUPPLEMENTAL MEDWATCH REPORT. ADDITIONAL PATIENT INFORMATION WAS SUBSEQUENTLY OBTAINED AND WAS ADDED TO SECTION "B5" OF THIS REPORT. THAT INFORMATION REPORTED THAT THE PHYSICIANS TREATING THE PATIENT REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED. THE PHYSICIANS FURTHER REPORTED THAT THE DIMINISHED PATIENT BRAIN FUNCTION WAS NOT CAUSED OR CONTRIBUTED TO BY THIS REPORTED EVENT. SECTION D3 WAS CHANGED TO REFLECT THE CORRECT MANUFACTURER OF THE SUSPECT MEDICAL DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. THE AUTOMATIC LMPELLA CONTROLLER (AIC) DATA LOGS WERE NOT ABLE TO BE ANALYZED AS THEY WERE UNABLE TO BE RETURNED, AS THEY HAD BEEN WRITTEN OVER DURING SUBSEQUENT AND DIFFERENT PATIENT USE AT THE USER FACILITY. UPON THE RETURN OF THE LMPELLA RP AN INSPECTION OF THE DEVICE WAS PERFORMED, WHICH REVEALED THAT THE PUMP TO BE IN GOOD CONDITION. THERE WERE NO SHARP PROTRUSIONS FOUND ON THE REPOSITIONING SHEATH. THE GUIDEWIRE WAS UNABLE TO BE EXAMINED AS IT WAS NOT RETURNED WITH THE LMPELLA RP AND REPOSITIONING SHEATH. DURING THE EXAMINATION OF THE PUMP BIOMATERIAL WAS FOUND ON THE IMPELLER. THE RETURNED LMPELLA RP WAS PERFORMANCE TESTED WITH AN AIC. THE DATA FROM THE TEST REVEALED THAT THE PUMP FLOW WAS IN SPECIFICATION FOR MOST OF THE TEST, BUT WAS BELOW SPECIFICATION FOR 10 SECONDS WHEN THE PUMP WAS INITIALLY SET TO P-8; DURING THIS TIME THE PUMP FLOW WAS AT 2.8 L/MIN WHEN THE EXPECTED RANGE WAS 3.4-4.2 UMIN. FLOWS IMPROVED TO THEIR EXPECTED RANGE AFTER A FEW SECONDS WHEN THE BIOMATERIAL WAS REMOVED FROM THE IMPELLER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED THAT DID NOT REVEAL ANY ANOMALIES, AND THAT THERE HAD NOT BEEN ANY OTHER REPORTED ISSUES FOR OTHER PUMPS IN THIS LOT RELEVANT TO THE FAILURE MODE. THE ROOT CAUSE OF THE LOW FLOW DURING THE CASE WAS MOST LIKELY LOW VOLUME DUE TO THE REPORTED BLEEDING. THE EVALUATION OF THE RETURNED LMPELLA RP WAS UNABLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE BLEED THAT ONLY BECAME APPARENT AFTER THE PATIENT WAS TURNED WITH THE RP AND LVAD IN PLACE. THE EVALUATION WAS UNABLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE LOW FLOW WAS MOST LIKELY LOW VOLUME DUE TO THE RETROPERITONEAL BLEED. THE ROOT CAUSE OF THE BLEED WAS MOST LIKELY A FEMORAL VEIN PUNCTURE DURING THE INITIAL STICK. INTERNAL REFERENCE (B)(4).
ADDITIONAL PATIENT INFORMATION WAS SUBSEQUENTLY OBTAINED AND WAS ADDED TO SECTION "B5" OF THIS REPORT. THAT INFORMATION REPORTED THAT THE PHYSICIANS TREATING THE PATIENT REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED. THE PHYSICIANS FURTHER REPORTED THAT THE DIMINISHED PATIENT BRAIN FUNCTION WAS NOT CAUSED OR CONTRIBUTED TO BY THIS REPORTED EVENT. SECTION D3 WAS CHANGED TO REFLECT THE CORRECT MANUFACTURER OF THE SUSPECT MEDICAL DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION. THE AUTOMATIC IMPELLA CONTROLLER (AIC) DATA LOGS WERE NOT ABLE TO BE ANALYZED AS THEY WERE UNABLE TO BE RETURNED, AS THEY HAD BEEN WRITTEN OVER DURING SUBSEQUENT AND DIFFERENT PATIENT USE AT THE USER FACILITY. UPON THE RETURN OF THE IMPELLA RP AN INSPECTION OF THE DEVICE WAS PERFORMED, WHICH REVEALED THAT THE PUMP TO BE IN GOOD CONDITION. THERE WERE NO SHARP PROTRUSIONS FOUND ON THE REPOSITIONING SHEATH. THE GUIDEWIRE WAS UNABLE TO BE EXAMINED AS IT WAS NOT RETURNED WITH THE IMPELLA RP AND REPOSITIONING SHEATH. DURING THE EXAMINATION OF THE PUMP BIOMATERIAL WAS FOUND ON THE IMPELLER. THE RETURNED IMPELLA RP WAS PERFORMANCE TESTED WITH AN AIC. THE DATA FROM THE TEST REVEALED THAT THE PUMP FLOW WAS IN SPECIFICATION FOR MOST OF THE TEST, BUT WAS BELOW SPECIFICATION FOR 10 SECONDS WHEN THE PUMP WAS INITIALLY SET TO P-8; DURING THIS TIME THE PUMP FLOW WAS AT 2.8 L/MIN WHEN THE EXPECTED RANGE WAS 3.4-4.2 L/MIN. FLOWS IMPROVED TO THEIR EXPECTED RANGE AFTER A FEW SECONDS WHEN THE BIOMATERIAL WAS REMOVED FROM THE IMPELLER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED THAT DID NOT REVEAL ANY ANOMALIES, AND THAT THERE HAD NOT BEEN ANY OTHER REPORTED ISSUES FOR OTHER PUMPS IN THIS LOT RELEVANT TO THE FAILURE MODE. THE ROOT CAUSE OF THE LOW FLOW DURING THE CASE WAS MOST LIKELY LOW VOLUME DUE TO THE REPORTED BLEEDING. THE EVALUATION OF THE RETURNED IMPELLA RP WAS UNABLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE BLEED THAT ONLY BECAME APPARENT AFTER THE PATIENT WAS TURNED WITH THE RP AND LVAD IN PLACE. THE EVALUATION WAS UNABLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE LOW FLOW WAS MOST LIKELY LOW VOLUME DUE TO THE RETROPERITONEAL BLEED. THE ROOT CAUSE OF THE BLEED WAS MOST LIKELY A FEMORAL VEIN PUNCTURE DURING THE INITIAL STICK. INTERNAL REFERENCE (B)(4).
ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIANS TREATING THE PATIENT REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED. THE PHYSICIANS FURTHER REPORTED THAT THE DIMINISHED PATIENT BRAIN FUNCTION WAS NOT CAUSED OR CONTRIBUTED TO BY THIS REPORTED EVENT.
ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIANS TREATING THE PATIENT REPORTED THAT THE PATIENT SUBSEQUENTLY EXPIRED. THE PHYSICIANS FURTHER REPORTED THAT THE DIMINISHED PATIENT BRAIN FUNCTION WAS NOT CAUSED OR CONTRIBUTED TO BY THIS REPORTED EVENT.
THE IMPELLA RP HAS NOT YET BEEN RETURNED FOR EVALUATION; CONSEQUENTLY NO DEVICE ANALYSIS COULD BE PERFORMED TO ASSIST IN FINDING A DEFINITIVE ROOT CAUSE OF THE EVENT. THE MANUFACTURER WILL CONTINUE TO INVESTIGATE ALL REASONABLE AND OBTAINABLE SOURCES OF INFORMATION AND WILL PROVIDE RESULTS AND CONCLUSIONS IN A SUPPLEMENTAL MEDWATCH REPORT IF THE DEVICE AND/OR ADDITIONAL INFORMATION IS RECEIVED. SINCE JULY OF THIS YEAR ABIOMED HAS HAD EMDR SUBMISSION PROBLEMS DUE TO TECHNICAL FIREWALL ISSUES. AS A RESULT ABIOMED WAS UNKNOWINGLY SUBMITTING TO THE TEST ENVIRONMENT SINCE JULY RESULTING IN 13 MDR'S NOT BEING SUBMITTED TO THE PRODUCTION ENVIRONMENT AND ARE SUBSEQUENTLY PAST THE 30 DAY WINDOW. WITH THE HELP OF THE EMDR TEAM THIS PROBLEM HAS BEEN RESOLVED. ON 11/16/2016 A CONFERENCE CALL WAS HELD BETWEEN ABIOMED AND FDA AND DUE TO THE UNIQUENESS OF THE SITUATION IT WAS AGREED ABIOMED WILL RE-SUBMIT THE 13 MDR'S IN THE PRODUCTION ENVIRONMENT AND NOTE IN SECTION H10 THE REASON FOR BEING BEYOND THE 30 DAY WINDOW IS DUE TO THE ISSUES DESCRIBED ABOVE. THIS MDR WAS ONE OF THE 13 AND WAS ORIGINALLY SUBMITTED IN THE TEST ENVIRONMENT ON 10/28/2016 AND THIS IS THE REASON IT IS BEING SUBMITTED BEYOND THE 30 DAY WINDOW. (B)(4).
COMPLAINANT REPORTED THAT ON (B)(6) 2016 THE CLINICIANS PLACED AN IMPELLA RP IN A (B)(6) MALE PATIENT FOLLOWING THE PATIENT'S TRANSFER TO ANOTHER FACILITY FOR A CABG, BUT HAD THEN RECEIVED A SURGICAL TURN DOWN. ON (B)(6) 2016 BI-VENTRICULAR ASSIST DEVICES (VAD) WERE PLACED. BETWEEN (B)(6) 2016 AND (B)(6) 2016 THE PATIENT WAS REPORTED TO HAVE HAD MULTIPLE MEDICAL ISSUES, INCLUDING MULTIPLE CODES AND CLOSTRIDIUM DIFFICILE COLITIS (C-DIF INFECTION.) ON (B)(6) 2016 THE PATIENT WAS TAKEN TO THE CATH LAB WERE THE CLINICIANS PLACED STENTS IN THE LM, LAD, RCA AND THE CIRCUMFLEX ARTERY. THEN ON (B)(6) 2016 A HEARTWEAR LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS PLACED IN THE PATIENT, AND ON (B)(6) 2016 THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) WAS REMOVED FROM THE PATIENT. ON (B)(6) 2016 THE IMPELLA RP WAS PLACED IN THE LEFT FEMORAL ARTERY, AS RIGHT VENTRICULAR FAILURE WAS PRESENT. IMPELLA FLOWS WERE ACHIEVED. THE IMPELLA RP PLACEMENT WAS REPORTED TO HAVE BEEN NORMAL AND STANDARD, ALTHOUGH WHEN CLOSING THE GROIN SITE THE PHYSICIAN NEEDED COACHING ON HOW TO PERFORM A MATTRESS SUTURE, AND THE MATTRESS SUTURES WERE PERFORMED. FOLLOWING THE IMPELLA RP PLACEMENT THE PATIENT WAS ALSO ADMINISTERED VASODILATORS AND EPINEPHRINE, AND SENT THE ICU DEPARTMENT. ON THE NIGHT OF (B)(6) 2016 FLOWS DROPPED IN BOTH THE IMPELLA RP AND THE LVAD AFTER THE PATIENT WAS TURNED IN BED. THE PATIENT'S HEMOGLOBIN/HEMATOCRIT HAD DROPPED, SO THE PATIENT WAS TAKEN FOR A CAT SCAN WHERE A LARGE RETROPERITONEAL BLEED OF UNKNOWN ORIGIN WAS FOUND. THE PATIENT WAS GIVEN 5 UNITS OF REPLACEMENT BLOOD, AND AFTER FLUID RESUSCITATION BOTH IMPELLA RP AND LVAD FLOWS RETURNED TO NORMAL, AND THE PATIENT'S CONDITION WAS STABLE. THE PLAN WAS TO STABILIZE THE PATIENT AND LEAVE ON IMPELLA AND LVAD SUPPORT. ON (B)(6) 2016 THE PATIENT WAS REPORTED TO HAVE BEEN DECOMPENSATING; THE PATIENT'S HEMOGLOBIN/HEMATOCRIT HAD DROPPED AND THE PATIENT WAS NOT OXYGENATING. THE DECISION WAS MADE TO REMOVE THE IMPELLA RP AND PLACE PATIENT BACK ON ECMO FOR OXYGENATION AND RIGHT VENTRICLE DECOMPRESSION. THE IMPELLA RP WAS DISCONTINUED AND REMOVED. THE PATIENT REQUIRED INTERVENTION OF 18 UNITS OF BLOOD PRODUCT, COIL EMBOLIZATION, AND 2 SURGICAL EVACUATIONS OF THE HEMATOMA AT THE LEFT FEMORAL ARTERY. THE 18 UNITS OF REPLACEMENT BLOOD WERE GIVEN OVER A 24 HOUR PERIOD. ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT REVEALED THAT THE PATIENT WAS UNSTABLE DUE TO MULTIPLE PROCEDURES AND SURGICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773169 | IMPELLA RP US HDE PUMP SET | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE | OJE | ABIOMED, INC | IMPELLA RP | 1248732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | Required Intervention |