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 2017-05-01 for IMPELLA IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[74062280]
The impella rp was not returned for evaluation, as it was discarded subsequent to the event. Therefore, no device analysis could be performed. The console logs were returned for analysis. The logs however do not contribute any information to the root cause of the event. There is no anomaly in the data logs, with the logs showing normal pump performance. The pulmonary bleed was most likely caused by repeated advancement and manipulation of guidewires into the pulmonary artery during the difficult positioning of the rp. No corrective action is recommended as the root cause was unable to be determined. Failures of this type will be monitored and trended. The manufacturer will continue to investigate all reasonable obtainable sources of information and will provide results and conclusions in a supplemental medwatch report if additional information is received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74062281]
A male patient of unknown age was admitted to the medical facility in right ventricular failure post placement of a left ventricular assist device (lvad) in (b)(6) of 2017. The patient was taken to the cardiac cath lab for placement of the impella rp for right sided heart support. The patient was accessed and a swan-ganz catheter was placed with some difficulty. The swan was exchanged out over an. 018 v18 wire and the impella rp was advanced. Of note in the ifu for the impella rp the wire recommendation is as such: "a 0. 025 inch, 260 cm platinum plus or similar stiff placement guidewire is used for the placement of the impella rp? Catheter" there is no recommendation to use a v18 wire for placement. There was placement difficulty as the wire was pulled back, and so the rp was removed and the swan re-advanced. The physician chose then to use a "buddy wire technique" and place the. 018 v18 wire and platinum plus wire into the left pulmonary artery via the swan. The rp was successfully then positioned over the. 025 wire and delivered appropriate flows. The lvad device also had improved flows with the rp support running concurrent. The patient was transferred to the icu for monitoring and placement of the rp was confirmed by x-ray and echo. During the next 2-4 hours the patient's condition deteriorated. There was question of bleeding into the patient's left lung. Although there was no proof, the physician believed that the bleeding was due to a pulmonary artery perforation from guidewire insertion. On the following day, the patient had the impella rp explanted, and extra corporeal membrane oxygenation (ecmo) placed. Ecmo and the lvad continue to support the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00031 |
| MDR Report Key | 6533786 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-01 |
| Date of Report | 2017-04-02 |
| Date of Event | 2017-04-02 |
| Date Mfgr Received | 2017-04-02 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2017-05-01 |
| 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 MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED INC. |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA |
| Generic Name | RIGHT VENTRICULAR BYPASS ASSIST DEVICE |
| Product Code | OJE |
| Date Received | 2017-05-01 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1230922 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN, 52074 GM 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2017-05-01 |