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 2016-04-20 for IMPELLAS CP IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[43157883]
The impella cp and the 14french introducer were returned for evaluation. The introducer was returned with the pump still inserted up the repositioning sheath. Close examination revealed a flattening of the introducer body in the middle third of the introducer shaft. There were no splits, tears, "cracking", "shredding" or other damage/anomalies observed. Leakage testing was performed that did not reveal any evidence of leakage at the valve/hub area at 300 mm hg. As reported of this report there was a significant amount of manipulation of the introducer during the case. Based on the deformity and the flattening of the shape of the shaft bleeding was possible. A definitive root cause for this event could not be definitively determined. The impella cp directions for use advises the operator of the following: to prevent failure of the peel-away introducer, remove the peel-away introducer prior to transport when activated clotting time (act) is less than 150 seconds. Remove the peel-away introducer completely from the artery over the catheter shaft to prevent trauma and significant bleeding and apply manual pressure above the puncture site. Grasp the two "wings" and bend back until the valve assembly comes apart. Continue to peel the two wings until the introducer is completely separated from the catheter shaft. A meeting with abiomed and the (b)(6) staff was held to review the case in question. During this meeting with the staff the proper use of the peel away sheath was discussed and demonstrated to the staff. In addition, "best practices" were established for the staff for the placement and support of patients with the impella cp, to insure better patient outcomes. Also, it was established that monthly training of the cardiac care unit and the catheterization lab would be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43157884]
The complainant reported that on (b)(6) 2016 the hospital was treating a female patient. The patient coded and cpr was performed. The patient survived, and an impella cp was then placed. Following placement of the pump in the catheterization lab (cath lab) and the patient immediately improved. The physician then intervened upon the patient's arteries. Following the repair of the arteries the patient was transferred to the cardiac intensive care unit (cicu). The physician had left the 14fr oscor in the patient but had not been peeled away as there was some slight oozing around it. The patient was transferred to the cardiac intensive care unit (cicu) and was successfully supported with the impella cp for over 5 hours, but during this support the staff thought the oozing was too brisk, so pressure was held on the site, but this led to more bleeding. The vascular surgeon called and a stitch was placed, but this did not lead to cessation of bleeding. The device was removed from the patient and manual pressure held until hemostasis was achieved. Once the pump was removed the patient became bradycardic, and then went into a pulseless electrical activity (pea) rhythm. This led to more cpr being performed and the patient was placed on epinephrine and dopamine drips. The patient then stabilized. Upon the removal of the oscor 14fr introducer it was reportedly found that the sheath had "shredded", and was thought to have been the cause of the bleeding from the femoral artery. Additional information from the complainant facility categorized the sheath as having "cracked". The patient was reported to have received (b)(4) units of replacement blood products. Two days following removal of the impella cp, on (b)(6), 2016, the patient expired. The facility staff reported that they did not believe that any issue with the sheath or the patient bleeding contributed to the patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00007 |
| MDR Report Key | 5591701 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-03-30 |
| Date Facility Aware | 2016-04-01 |
| Date Mfgr Received | 2016-04-01 |
| Device Manufacturer Date | 2016-02-22 |
| Date Added to Maude | 2016-04-20 |
| 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 (GERMANY) |
| Manufacturer Street | NEUEHOFER WEG 3 |
| Manufacturer City | AACHEN, GERMANY 13059, GM |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 13059, GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLAS CP |
| Generic Name | IMPELLA CP |
| Product Code | PBL |
| Date Received | 2016-04-20 |
| Returned To Mfg | 2016-04-08 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1224141 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 36 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE, GMBH (GERMANY) |
| Manufacturer Address | NEUEHOFER WEG 3 AACHEN, GERMANY 13059, GM GM 13059, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-20 |