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 2016-02-10 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[37922621]
Following the reported issue removing the device from the patient, and the subsequent required surgery to remove the detached portions of the impella cp cannual, the physician reported that he did not clearly understand that attempting to remove an impella through the percolse sutures is not recommended by abiomed or abbott, the manufacturer of the perclose device. The abiomed representative has provided retraining of the physician and the cath lab manager and staff. In addition, the abiomed representative has set up future in-service dates to help educate any new staff members and to provide ongoing education to the team. The impella cp was not returned for evaluation, so no device analysis could be performed. The manufacturer will continue to investigate all reasonable obtainable sources of information and will provide results and conclusions in a supplemental medwatch report if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[37922622]
The complainant reported that a (b)(6) male cardiomyopathy patient had an impella cp placed using a perclose on (b)(6) 2016. The patient was reported to have clean arteries, and was diagnosed as takotsubo. The patient was supported with the pump for 66. 13 hours. The patient was reported to have been doing well. All drips were stopped and the weaning process was begun on (b)(6) 2016. The impella cp patient support was reported as successful. On (b)(6) 2016 the pump was explanted from the patient. The physician explained that during explant the nurse helping in the procedure paused while pulling the device out, as she had observed blood coming from the outlet area and then stopped pulling. At that moment the physician was cinching down the sutures. After much force the device broke free and he was able to complete the pre-close process, and again there was bleeding observed from the site. The patient was reported to have remained in stable condition during the removal of the impella cp. Following removal of the impella cp the physician noticed a "spring like" wire coming from the femoral artery. It was also noticed that the pigtail was not present. The physician explained that it appeared that the cannula had come apart leaving the pigtail, the inlet and part of the cannula still in the common femoral artery. The patient was then taken to surgery for removal of the remaining portions of the catheter. All remaining portions or the cannula were successfully removed from the patient. The patient was reported to have subsequently expired on (b)(6) 2016. The physician stated that the patient outcome was not as result of any issue with the device, but was due to the underlying heart issues that brought the patient to the hospital.
Patient Sequence No: 1, Text Type: D, B5
[40744437]
Following the submittal of the initial mdr by abiomed for this event, the customer submitted user mdr report 199273664-2016-0001. This user mdr provided additional information not submitted on the initial mdr, and reported different information than was originally reported on abiomed's initial mdr. This supplemental mdr is correcting information previously submitted, adding additional information reported by the customer in their user mdr and additional information obtained during meetings with the complainant, and an abiomed's clinical review of the event. Corrected information: death: (b)(6) 2016. Relevant tests/laboratory data, including dates: (b)(6) 2016 @ 05:17 hgb 8. 7 hct 26. 2, (b)(6) 2016 @ 14:45 hgb 8. 0 hct 25. 9, (b)(6) 2016 @ 15:10 lactic acid 5. 6, (b)(6) 2016 @ 11:14 lactic acid 1. 8, (b)(6) 2016 @ 11:14 ck 631 trop 41. 72 all high, but down from high values of (b)(6) 2016 @ 05:17 ck 998 ck-mb 134. 6. Other relevant history, including preexisting medical condition: nstemi, history of hypothyroidism, no known allergies,. This visit-septic shock , acute coronary syndrome, cad with stenosis of lad, atrial fibrillation, cardiogenic shock, takotsubo cardiomyopathy, acute coronary syndrome. Concomitant products: left internal jugular 3 lumen central venous catheter (b)(6) 2016. Clinical review of the event this was an implant of an impella cp on (b)(6) 2016 at 20:33 for takotsubo cardiomyopathy. In addition to takotsubo, the (b)(6) year old patient presented with septic shock, acute coronary syndrome, coronary artery disease (cad) with stenosis of the left anterior descending (lad) artery, atrial fibrillation, cardiogenic shock and a non-st elevated myocardial infarction (nstemi). The patient had a previous medical history of hyperthyroidism. The impella cp was implanted along with a perclose suture mediated closure (smc) system (abbott laboratories), utilizing the preclose technique for post-explant hemostasis. After implant on (b)(6) 2016, the patient was reported as doing well. All drips were stopped and the weaning process was begun on (b)(6) 2016. The following day, the pump was explanted. During removal of the impella, the physician reported the nurse pulling the impella out hesitated when she saw blood coming from the arteriotomy site. At the same time, the physician was cinching down the sutures on the perclose smc device. It was reported that removal of the impella pump required great force before the physician could complete the perclose procedure. Following removal of the impella pump, bleeding continued from the arteriotomy site. In consultation with an abiomed clinical representative, the physician reported seeing a "spring-like" wire coming from the patient's femoral artery. He also stated there was no pigtail present on the explanted impella catheter. It was concluded that the cannula had come apart during the removal of the impella, leaving the pigtail, inflow cage and distal part of the cannula in the patient's common femoral artery. The patient was taken to vascular surgery to have the pump components removed. After surgery the patient was transferred to the cardiac icu where he suffered a cardiac (pea) arrest and expired at 15:20 on (b)(6) 2016. Following the case, an abiomed clinical representative met with the physician and the catheter lab manager to discuss the case. It was reported that the physician did not understand that attempting to remove an impella through the perclose sutures is not recommended by abiomed or abbott. The abiomed representative has provided retraining of the physician and the cath lab manager and staff. The abiomed representative also set up future in-service dates to providing ongoing education to the team and any new staff members. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220648-2016-00002 |
| MDR Report Key | 5427992 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-02-10 |
| Date of Report | 2016-01-11 |
| Date of Event | 2016-01-11 |
| Date Facility Aware | 2016-01-11 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2015-09-14 |
| Date Added to Maude | 2016-02-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 CP |
| Generic Name | IMPELLA CP |
| Product Code | PBL |
| Date Received | 2016-02-10 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1203967 |
| Device Expiration Date | 2017-06-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | R |
| 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. Death; 2. Required No Informationntervention | 2016-02-10 |