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 2017-11-07 for IMPELLA RP 004334 manufactured by Abiomed, Inc..
[91247160]
The products involved in this event were discarded by the user. A review of the clinical case revealed the implanting physician reported the patient's heart was in very poor condition and was "falling apart... Like paper tearing. " after the patient's heart was repaired the right heart began pumping again and the patient was stable. An abiomed physician also reviewed the case and believes the perforation was due to the continued manipulation of the guidewires and guiding catheters. The root cause of the right heart perforations during manipulation of the various guidewires and catheters was most likely due to the patient's friable cardiac tissue. 17-0985.
Patient Sequence No: 1, Text Type: N, H10
[91247161]
An impella rp was implanted into a (b)(6) female patient for support for an off-pump coronary artery bypass. The patient presented with an ejection fraction range of 35-40%, with a friable (thin and weak) right atrium. After the bypass, the clinical team was unable to float the swan to the left pulmonary artery using a pigtail catheter, thefore the catheter was exchanged for a multipurpose catheter. The multipurpose catheter was removed and the impella rp was inserted. Insertion of the impella rp was difficult and the physician noted the guide wire was difficult to advance, and he was unsure whether the guide wire was in the right place. The impella rp was unable to advance into the left pulmonary artery despite several attempts. During these attempts the patient went into atrial fibrillation, and the patient's right atrium and right ventrical were perforated. The right heart was repaired with sutures and began to pump again. The patient was reported to be in stable condition and there was no indication of further adverse effect to the patient following the surgical repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00094 |
| MDR Report Key | 7006583 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-10-13 |
| Date Mfgr Received | 2017-10-16 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2017-11-07 |
| 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 MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN, 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 |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2017-11-07 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1276209 |
| Device Expiration Date | 2019-01-31 |
| 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. Required No Informationntervention | 2017-11-07 |