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 2016-06-16 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[47527138]
The impella cp kit, which includes the 14 fr oscor sheath, dilator and repositioning sheath were all returned for evaluation. The inspection of the impella cp kit revealed visible damage to the impella cp, 14 fr oscor sheath, dilator, and repositioning sheath. The pump catheter had been cut in 2 places, with approximately 70cm of the catheter missing. The repositioning sheath was found to be severely damaged. The console logs were also returned for analysis. The log analysis revealed that the pump was moved out of position 10 minutes after it was started and remained in the wrong position until it was disconnected after 25 minutes. The visual examination of the pump, repositioning sheath and oscor sheath determined that the cause of this event was the impella cp being placed in a morbidly obese patient. After the pump was implanted, blood was leaking rapidly from the 14 fr oscor sheath. The oscor sheath was peeled back and the physician tried inserting the repositioning sheath. The femoral artery was very deep and the access angle was steep. The repositioning sheath would not enter the artery, and when greater force was applied, the wound closure on the repositioning sheath failed and was severely damaged resulting in the patient bleeding. The root cause of this failure was excessive force applied due to patient condition. As the failure was caused do to patient condition, no corrective action is recommended at this time. The instructions for use of the impella cp warns the user of the following: when securing the repositioning sheath, vascular closure may be difficult in obese patients with extensive adipose tissue. The instruction for use of this device also instructs the user of the following: before initiating the procedure, evaluate the patient for factors that may prevent successful placement of the impella? Catheter {such as} obesity the investigation also included an investigation of the continued patient bleeding. The inspection of the 14fr oscar sheath revealed that the hemostatic valve was torn in an irregular pattern, and evidence was found of the silicone having reconnected along the valve slits, causing an insufficient seal. The root cause of the bleeding was a valve defect on the top and bottom valves in the 14 fr oscor sheath. No corrective action is recommended at this time due to the low risk of this failure mode. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[47527139]
The complainant reported that on (b)(6) 2016 a (b)(6) old morbidly obese male patient with systolic congestive heart failure was admitted to the coronary care lab (ccl) to undergo a primary percutaneous coronary intervention (ppci) for complex multi-vessel coronary artery disease (which included a long occlusion of the left anterior descending artery [lad], a circumflex coronary artery (cx-om) lesion and a severely diseased right coronary artery). The patient also had a compromised ejection fraction of 20%. As a result of the patient's large body mass index and the hemodynamic burden that would occur during this complex pci the physician chose to place the impella cp in the patient. The impella cp was successfully placed in the patient. Shortly following pump placement it was noted that there was pulsatile blood jetting back from the hemostatic valve of the oscor sheath. The impella was moved back 2cm, as it was out of the apex, but significant blood loss continued. Another clinician moved above the arteriotomy and held pressure while the physician removed the peel away sheath from artery, then peeled away and flushed the repositioning sheath. Multiple attempts were made to advance the repositioning sheath into femoral artery, but it would not pass. Another attempt was made to slide the repositioning sheath into femoral artery without success. The clinician was holding pressure above insertion stick but the patient continued to bleed profusely. At this point another physician assisted the doctor and performed contralateral balloon tamponade from the rfa to the lfa and ballooned alongside the impella catheter at the left femoral artery (lfa) access site. This helped with the bleeding. The first physician then attempted to insert repositioning sheath pulled on the impella catheter and pushed the repositioning sheath at the same time for increased pushability, but this did not work. He then cut the impella catheter and attempted to place a 10fr, 12 fr, 14fr cook sheath over the impella catheter, but none fit onto impella catheter, as each sheath just crumpled up at entry site without the dilator. The patient had now lost a significant amount of blood, estimated to be between 750cc's and 1 liter and was hemodynamically unstable. The patient was then started on levophed at 20mcg/min and dopamine at 10mcg/kg/min. The patient was also administered 3 units of blood during this time. His blood pressure got as low as 60/40. The patient became more responsive with better arterial control with the balloon tamponade and manual pressure along with levophed , dopamine and blood products and was alert and oriented. The patient was brought to surgery to remove the device and close the artery. A cut down to femoral artery was performed which revealed an extremely deep femoral artery. The physician reported that he felt the deep femoral artery explained why the repositioning sheath would not advance, as it was straight down and the strength of the impella catheter was not enough to carry the repositioning sheath all the way into the common femoral artery. The femoral artery repair was completed, and it was reported that there was no permanent patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00015 |
| MDR Report Key | 5729317 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-16 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-05-17 |
| Date Facility Aware | 2016-05-17 |
| Date Mfgr Received | 2016-05-17 |
| Device Manufacturer Date | 2016-05-12 |
| Date Added to Maude | 2016-06-16 |
| 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 | ABIOMED, INC. 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 | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-06-16 |
| Returned To Mfg | 2016-05-31 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1234144 |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 5 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 | 2016-06-16 |