MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-01-12 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[97091967]
The impella rp was returned for evaluation; however the introducer and guidewire used in this event were discarded following use. The console data logs were returned, and the analysis of the logs revealed 6 brief continous suction alarms that were triggered after the pump was repositioned. The visual inspection of the impella rp identified evidence of kinking and twisting of the canula. These deformation were likely caused by the repeated attempts to positon the pump due to the patient's unusual anatomy. Without the guidewire and introducer used during this event, a more comprehensive evaluation was unable to be performed. A review of the device history record and the lot analysis indicated all applicable systems were deemed adequate and remain effective. In conclusion, the root cause of the positioning issues was the patient's cardiac anatomy. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97091968]
The complainant reported that a (b)(6) year old male patient presented to the hospital a couple of days previous to (b)(6) 2017 after having "c/o indigestion". The patient was having an acute myocardial infarction (ami) with right ventricular failure. The physician scheduled the patient for an impella rp placement procedure. The patient was brought to the cardiac catheterization lab on (b)(6) 2017 where the impella rp was placed via the right femoral artery (rfa) using a swan catheter, and then exchanged the swan for an. 027 wire deep into the left pulmonary artery. The pump was tracked over wire and flows reached 4. 2 lpm; however upon watching the patient under fluoroscope in the anteroposterior (ap) view, the device placement was in question. A right anterior oblique, radiographic projection was done, which revealed that the posterior anterior view was due to the patient's anatomy, and not because the device was mal-positioned. The physician then attempted to place the device again but a second ap view revealed the same issue. It was then decided to leave the device in the patient and remove the peel-way sheath. The peel-way of the sheath went very well until the mattress suture was deployed. A nurse held the held manual pressure for 10 minutes, but noted gushing of blood as the mattress sutures were not supporting hemostasis. The patient was reported to have lost approximately 2 ml of blood during this event, and an unknown amount of replacement blood products were administered to the patient. Another physician attempted to place multiple sutures with deep tissue bites, but the patient's girth and size precluded all attempts to control the bleeding. At this point the repositioning sheath had been manipulated by the suturing attempts and was pulled back. The first physician then attempted to reposition the pump in the pa but was unsuccessful, and the device hinged in the right atrium and came out of the pa. Without sheath access and the wire the doctor was unable to reposition the device. The impella rp was removed from the patient and a. 035 stiff wire was from another impella rp kit was used to retain access for new sheath placement. This was done by placing the wire through the inlet cage and removing device over the wire. A new 23fr peel-away sheath was placed in the right femoral artery, and another impella rp was placed in the patient. The replacement device successfully supported the patient for 57. 62 hours, but the patient was reported to have expired on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00126 |
| MDR Report Key | 7185613 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-13 |
| Date of Event | 2017-12-13 |
| Date Mfgr Received | 2017-12-13 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9788828068 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074, GM, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-01-12 |
| Returned To Mfg | 2017-12-21 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1309261 |
| Device Expiration Date | 2019-09-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074, GM, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-12 |