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 2016-04-29 for IMPELLA RP 004334 manufactured by Abiomed Europe, Gmbh (germany).
[44120298]
The root cause of this spr was determined to be a high cumulative (3. 8 day implant duration) load imparted to the cannula. The high cumulative loading of the cannula was due to a challenging device placement; along with the fact that once the pump was in place, a constant high loading force was imparted on the cannula during the days of support. This resulted in the deformation of the connection interface between the cannula and the pump housing. The deformation weakened the epoxy bond between the cannula and pump housing, resulting in the failure observed during pump removal. Corrective action retraining: training currently includes education of users on the potential for a high residual load on the cannula during challenging device placements. The abiomed representative reported that following this event a review was performed with the staff on how to manage the use of the product during high residual load on the cannula during device placements. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44120299]
The complainant reported that a (b)(6) male post lvad patient had been successfully supported by an impella rp for over 3 days when the physician attempted to remove the pump at the patient's bedside. The sutures were removed and the device was pulled back, but only the portion of the pump, up to the inlet cage, was removed from the patient. The patient was then taken to the cath lab where fluoro images were taken. The fluoro images revealed that the rest of the device was intact and was located in the iliac area. The physician then successfully removed the detached portion of the device from the iliac area with the aid of 2 snares and a balloon through a 24 french sheath. No cutdown was necessary and just manual pressure was necessary following the device removal. The complainant reported that there was no harm to the patient as are result of the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00008 |
| MDR Report Key | 5621066 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-29 |
| Date of Report | 2016-03-31 |
| Date of Event | 2016-03-31 |
| Date Facility Aware | 2016-03-31 |
| Report Date | 2016-03-31 |
| Date Reported to Mfgr | 2016-03-31 |
| Date Mfgr Received | 2016-03-31 |
| Device Manufacturer Date | 2015-12-30 |
| Date Added to Maude | 2016-04-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | IMPELLA RP |
| Generic Name | IMPELLA |
| Product Code | PBL |
| Date Received | 2016-04-29 |
| Returned To Mfg | 2016-04-04 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1218232 |
| Device Expiration Date | 2017-10-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 122 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 | 2016-04-29 |