MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-17 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[52383224]
The impella cp and 14fr introducer sheath were not returned for evaluation, as they are currently being held in the complainant's risk management department. Therefore, to date, no analysis can be performed. It is unclear at this point if the artery and any abnormalities of patient anatomy in the vascular bed could have contributed to the blood loss and noted "deformed" sheath. Furthermore, it is unclear if patient habitus could have contributed to the issue. Of note in the ifu there is a warning to observe for obesity and severe peripheral arterial obstructive disease before initiating the procedure, as obesity and pvd are factors that can prevent successful placement of the impella catheter. The patient involved in this event was documented to be obese. The physician had noted resistance which could have been a sign of pvd. The manufacturer will continue to investigate this complaint and all reasonable sources of information. Upon release and return of the device an evaluation and investigation will be conducted and the ensuing conclusions will be reported in a supplemental medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[52383265]
Complainant reported that on (b)(6) 2016 a (b)(6) obese female was being treated for cardiogenic shock and an acute anterior mi in the cath lab. She was noted to need the vasopressor, levophed, to maintain a systolic blood pressure above 90mm hg, and her anticoagulation was regulated by iv infusion of angiomax. The physician completed his angioplasty of the left anterior descending artery and had slow flow, concurrent with the cardiogenic shock, which prompted the decision to place an impella cp for support. The physician did the recommended serial dilations utilizing an 8 then 10 then 12 french dilator to prep the artery for installation of the 14fr oscor sheath. The sheath was placed. When the physician attempted to insert the impella cp through the 14fr sheath there was resistance felt and blood was flowing back from the sheath and a hematoma was forming at the insertion site. The team examined the groin and sheath under fluoroscopy and noted that the sheath had deformed. The decision was made to remove the sheath. Two staff members applied manual pressure to achieve hemostasis. The manual pressure was stopped and the femostop (manufactured by st. Jude medical/abbott) was placed prior to discharge from the cath lab suite and transfer to the icu for continued monitoring. The groin was resolving at the time and noted to be "soft". The complainant monitored the patient in the icu for 4 hours and then chose to begin the weaning of the femostop. Five minutes after the femostop was removed the patient again had a spontaneous and significant blood loss from the arterial access site and hypotension. The patient was taken to the operating room for a vascular repair. The repair was an interposition graft performed by vascular surgery. The post-operative recovery was a good one and the patient was discharged home with no permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00022 |
| MDR Report Key | 5883951 |
| Date Received | 2016-08-17 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-07-19 |
| Date Facility Aware | 2016-07-19 |
| Report Date | 2016-07-19 |
| Date Reported to Mfgr | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Device Manufacturer Date | 2016-07-06 |
| Date Added to Maude | 2016-08-17 |
| 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 13059GM |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 13059 GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMPELLA CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-08-17 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1240716 |
| Device Expiration Date | 2018-04-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 13 DA |
| 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. Required No Informationntervention | 2016-08-17 |