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 2016-12-20 for IMPELLA RP 004334 manufactured by Abiomed, Inc.
[62905895]
The products involved in this event were discarded by the user subsequent to the event. The manufacturer will continue to investigate all reasonable obtainable source information, and will provide them on a supplemental medwatch report if they become available. Device discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[62905896]
The complainant reported that on (b)(6) 2016 a (b)(6) female patient with a history of indeterminate stress echo, presented to the emergency room with cardiac pain. An ekg was performed which revealed non-specific t-wave elevation changes, and possible apical hypokinesis. The patient further presented with atrial fibrillation (afib) and a vaso-vagal event with chest pain. Ventricular septal defect closure surgery was performed. The patient then went into cardiogenic shock while being supported with an intra-aortic balloon pump and while being administered with maximum pressors and inotropes. The patient was then brought into the cardiac care laboratory for an emergent impella rp placement, as there were escalating pulmonary blood pressures. The patient's hemodynamics were evaluated and resulted in an impella cp also being placed. The patient was successfully supported for 22 hours, as the physician planned to continue to allow the heart to rest. , and then to wean the pressors, as tolerated. The following evening during the physician's attempt to reposition the impella rp the right ventricle was perforated. The patient coded and the patient's chest was immediately opened in an attempt to repair the rv perforation, but the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00044 |
| MDR Report Key | 6190639 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-20 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-11-23 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 2016-06-23 |
| Date Added to Maude | 2016-12-20 |
| 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. WILLIAM BOLT |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461451 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074, GM, GERMANY |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE |
| Product Code | OJE |
| Date Received | 2016-12-20 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1239146 |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-12-20 |