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 2017-11-02 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[90899305]
The impella rp and repositioning sheath were discarded by the user following patient use, so an evaluation of the device and event were unable to be performed. The console data log analysis is not applicable to this failure mode. There were no complaints for any other pump in this pump set lot. There were five other sprs associated with this 23 fr rp introducer lot. Three of the complaints were directly related and displayed the same failure mode. This failure mode has a medium risk assessment based on low occurrence (0. 5%, 2 occurrences out of 393 uses from 2016-10-16 to 2017-10-16) and major severity. The root cause of the broken sheath was unable to be determined because the product was not returned. No corrective action is recommended because the root cause was unable to be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90899306]
The complainant reported that on (b)(6) 2017 a (b)(6) male patient had undergone a cervical disk repair. During the following overnight the patient suffered a myocardial infarction (mi) and heart rhythm changes. It was reported that the patient had previously undergone coronary artery bypass graft procedures. At approximately noon on (b)(6) 2017 the patient was transported to the cath lab. The patient was found to be in biventricular failure. The physician decided that the patient required right and left heart hemodynamic support. An impella cp was placed for left side heart support. The physician then attempted to place an impella rp for right side heart support. The rp impella insertion was reported as very difficult. During the insertion the 23fr peel away cracked near hemostatic valve while inserting the dilator. Further examination of the sheath found that it was cracked and partially split on proximal portion near flush side arm. The physician was unsure if the crack happened prior to or when the dilator was placed within it. A large kelly clamp was placed around the sheath to keep together. The impella rp was then successfully placed. Hemodynamic support was provided and resulted in the patient's right ventricle being no longer extended. At least 1 unit of blood product was given in the ccl. It was reported that the patient was a bleeder due to anticoagulation from the spinal surgery that had been performed the previous day. The right coronary artery (rca) graft occlusion was successfully repaired. The patient was then successfully supported for 5. 09 hours, with no additional impella rp issues reported. The patient was reported to be in stable condition following the impella rp support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00088 |
| MDR Report Key | 6997195 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-02 |
| Date of Report | 2010-10-06 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2017-10-06 |
| Device Manufacturer Date | 2015-12-16 |
| Date Added to Maude | 2017-11-02 |
| 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 | 2017-11-02 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1216991 |
| Device Expiration Date | 2017-10-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-02 |