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 2016-11-22 for IMPELLA RP US HDE PUMP SET 00434 manufactured by Abiomed, Inc.
[60674135]
The impella rp has not yet been returned for evaluation; consequently no device analysis could be performed to assist in finding a definitive root cause of the event. The manufacturer will continue to investigate all reasonable and obtainable sources of information and will provide results and conclusions in a supplemental medwatch report if the device and/or additional information is received. Since july of this year abiomed has had emdr submission problems due to technical firewall issues. As a result abiomed was unknowingly submitting to the test environment since july resulting in 13 mdr's not being submitted to the production environment and are subsequently past the 30 day window. With the help of the emdr team this problem has been resolved. On 11/16/2016 a conference call was held between abiomed and fda and due to the uniqueness of the situation it was agreed abiomed will re-submit the 13 mdr's in the production environment and note in section h10 the reason for being beyond the 30 day window is due to the issues described above. This mdr was one of the 13 and was originally submitted in the test environment on 10/28/2016 and this is the reason it is being submitted beyond the 30 day window. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60674136]
Complainant reported that on (b)(6) 2016 the clinicians placed an impella rp in a (b)(6) male patient following the patient's transfer to another facility for a cabg, but had then received a surgical turn down. On (b)(6) 2016 bi-ventricular assist devices (vad) were placed. Between (b)(6) 2016 and (b)(6) 2016 the patient was reported to have had multiple medical issues, including multiple codes and clostridium difficile colitis (c-dif infection. ) on (b)(6) 2016 the patient was taken to the cath lab were the clinicians placed stents in the lm, lad, rca and the circumflex artery. Then on (b)(6) 2016 a heartwear left ventricular assist device (lvad) was placed in the patient, and on (b)(6) 2016 the right ventricular assist device (rvad) was removed from the patient. On (b)(6) 2016 the impella rp was placed in the left femoral artery, as right ventricular failure was present. Impella flows were achieved. The impella rp placement was reported to have been normal and standard, although when closing the groin site the physician needed coaching on how to perform a mattress suture, and the mattress sutures were performed. Following the impella rp placement the patient was also administered vasodilators and epinephrine, and sent the icu department. On the night of (b)(6) 2016 flows dropped in both the impella rp and the lvad after the patient was turned in bed. The patient's hemoglobin/hematocrit had dropped, so the patient was taken for a cat scan where a large retroperitoneal bleed of unknown origin was found. The patient was given 5 units of replacement blood, and after fluid resuscitation both impella rp and lvad flows returned to normal, and the patient's condition was stable. The plan was to stabilize the patient and leave on impella and lvad support. On (b)(6) 2016 the patient was reported to have been decompensating; the patient's hemoglobin/hematocrit had dropped and the patient was not oxygenating. The decision was made to remove the impella rp and place patient back on ecmo for oxygenation and right ventricle decompression. The impella rp was discontinued and removed. The patient required intervention of 18 units of blood product, coil embolization, and 2 surgical evacuations of the hematoma at the left femoral artery. The 18 units of replacement blood were given over a 24 hour period. Additional information received from the complainant revealed that the patient was unstable due to multiple procedures and surgical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00036 |
| MDR Report Key | 6121063 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-22 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-09-29 |
| Report Date | 2016-09-29 |
| Date Reported to Mfgr | 2016-09-29 |
| Date Mfgr Received | 2016-09-29 |
| Device Manufacturer Date | 2016-09-07 |
| Date Added to Maude | 2016-11-22 |
| 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, 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 RP US HDE PUMP SET |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2016-11-22 |
| Model Number | IMPELLA RP |
| Catalog Number | 00434 |
| Lot Number | 1248732 |
| Device Expiration Date | 2018-03-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 22 DA |
| 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. Required No Informationntervention | 2016-11-22 |