MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-07 for IMPELLA RP PUMP SET, EU 0046-0011 manufactured by Abiomed Europe Gmbh.
[76859053]
The impella rp was not returned for evaluation, as it was discarded subsequent to the event. Therefore, no device analysis could be performed. Photos of the suspect 23fr introducer were forwarded to the manufacturer for review. A device history review was performed, as well as a lot analysis. Impella rp pump set (0046-0011; s/n (b)(4)) contained 23fr introducer kits originating from batch c1-12705. The 23fr introducer kits originating from batch c1-12705 were inspected at the time of receipt. No relevant issues were found during the incoming inspection of the introducers. In addition, the lot analysis revealed that there were no relevant introducer complaints found that were linked to any other pump set containing introducer kits originating from batch c1-12705. The clinical narrative describes severe bleeding originating from a crack at the 23fr introducer sheath hub. This account was verified with the submission to the manufacturer of two photos showing complaint condition, and confirming the failure to have happened. Because the device was discarded no detailed engineering analysis could be conducted for this failure. Without the product returned for evaluation the root cause of this event is unable to be determined. Because the root cause was unable to be determined, no corrective action is recommended at this time. The failure will continue to be monitored and trended. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76859054]
On (b)(6) 2017 the physicians placed an impella cp in a (b)(6) female patient. The impella cp was placed in the common iliac artery. A cct scan was done which revealed severe pulmonary edema with massive pleura effusion on both sides. The physician made the decision to remove the pump and to then re-insert it in the left ventricle and then to add an impella rp for central perfusion. A tricky wireless re-insertion of the cp occurred with the aortic valve not opening, and with nearly no left ventricle pulsatility. Impella rp placement was begun, but after removal of the 23 fr introducer occurred there was severe patient bleeding from a cracked valve assembly on the introducer. The physician was then able to perform a quick and easy insertion and placement of rp, and the physician was able to change to the repositioning sheath. After placing/starting the rp it was immediately necessary and crucial to place an additional av-ecmo cannula to provide oxygenated blood the central circuit. Loss of patient blood occurred and was estimated not to be over 15 ml/min, with an approximate total of 300 to 500 ml. The patient was reported to have required replacement blood products (rbc, tc, ffp) before, during and after implantation of the impella cp and impella rp, as a result of the patient very critical condition. With the patient's heart doing well the impella rp was successfully weaned from the patient and the device was removed. The patient was successfully supported with both the impella cp and impella rp for 24 days. Upon removal of both impella pumps the patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00045 |
| MDR Report Key | 6618440 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-07 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2017-03-31 |
| Date Added to Maude | 2017-06-07 |
| 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, 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP PUMP SET, EU |
| Generic Name | RIGHT VENTRICULAR BYPASS ASSIST DEVICE |
| Product Code | OJE |
| Date Received | 2017-06-07 |
| Model Number | IMPELLA RP |
| Catalog Number | 0046-0011 |
| Lot Number | 1276464 |
| Device Expiration Date | 2018-12-31 |
| 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 | 2017-06-07 |