MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for IMPELLA RP US HDE PUMP SET US 004334 manufactured by Abiomed, Inc.
[60878172]
The device, with the exception of the detached portion of the cannula, has been returned for evaluation; the evaluation is currently being performed. Upon the completion of the evaluation of the impella rp a supplemental medwatch report containing the results and conclusions will be submitted. Resolved. (b)(4).
Patient Sequence No: 0, Text Type: N, H10
[60878173]
The complainant reported that they were treating a very large patient with significant amounts of adipose tissue between the vein and skin. This patient had known cardiac disease and was in the hospital for mitral valve repair. On (b)(6) 2016 an impella 5. 0 was placed in the patient for left side support. On (b)(6) 2016 it was determined that the patient was in need of escalated support due to right ventricle failure; consequently, an impella rp was also placed. Access and placement of the rp was done in the usual fashion. Pump flows were not optimal due to an extremely low pulsatility and low mean arterial pressures. To augment support and improve flow the patient received multiple transfusions of red blood cells (prbc), plasma (ffp), and albumin. Flows improved, as did mean arterial pressure. The physician chose not to remove the oscor peel away sheath at this time, so that they would have arterial access should the patient require escalation of care with an ecmo at a later time. The patient was then discharged to the icu for care. In the overnight, the patient was monitored to see if more blood and volume would be needed. The chest tubes were also monitored for output, and the patient did demonstrate progress on support. The iv medications were able to be weaned down. Due to this fact, the team decided to peel away the oscor sheath and to position the impella rp's repositioning sheath, as an ecmo was no longer felt to be necessary. The patient was provided dialysis during the day for volume control. During the second day the patient demonstrated improvement & was provided with dialysis. During the second evening of impella rp support, the pump flows were reducing. More volume was given in the form of prbcs and albumin. Unfortunately, flows did not improve and the patient was deteriorating with rising lactate numbers (ldh), and was becoming coagulopathic and acidotic. The team also performed a chest x-ray to confirm proper position within the right ventricle. Because the pump was in the proper position, the decision was made to explant the impella rp. Upon explant, there was resistance felt by the physician. Upon inspection it was discovered that the pump had come apart into two pieces, with the pump and motor portion remaining lodged in the femoral vein. As the patient was at risk with the coagulopathy to undergo a surgical removal of the rp, the team decided to wait until the patient's bleeding risk improved. While the team was awaiting an improvement in the bleeding risk, the patient's family chose to withdraw the patient's care. The patient expired and the detached portion of the rp cannula remains within the patient post-mortem.
Patient Sequence No: 0, Text Type: D, B5
[61427845]
The impella rp was returned without the cannula, as the cannula was apparently discarded subsequent to use. A visual inspection of the returned portion of the device was performed. The inspection revealed that the delo adhesive had filled the etchings of the laser-etched bonding surface, but there was minimal adhesive coverage over the rest of the surface. The evaluation of the returned portion of the impella rp revealed that the pump most likely separated during explant due to the pressure applied at the venous access site and the steep insertion angle required by the patient's size. The patient had been reported by the complainant as very large, and with significant amounts of adipose tissue between the vein and the patient's skin. Manual pressure is applied during explant from arterial sites, and not as regularly at venous sites. The level of pressure applied was increased due to the depth of the femoral vein due to the patient's size. The depth of the patient's vein would also require a steeper insertion angle. The increased load required to explant the catheter against the manual pressure through the sharp angle of venous access may have caused the failure of the delo adhesive joint, which caused the cannula to detach from the pump. The root cause of the cannula detachment was most likely the load created by the steep insertion angle and high manual pressure applied during explant due to the patient's size. Corrective action: a capa was opened to address rp cannula detachments. Failures of this type will continue to be monitored and tracked. (b)(4) supplement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220648-2016-00031 |
| MDR Report Key | 6119035 |
| Date Received | 2016-11-21 |
| Date of Report | 2016-08-31 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2016-11-02 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2016-11-21 |
| 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, INC |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP US HDE PUMP SET US |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2016-11-21 |
| Returned To Mfg | 2016-09-06 |
| Model Number | IMPELLA RP US HDE PUMP SET |
| Catalog Number | 004334 |
| Lot Number | 1212833 |
| Device Expiration Date | 2018-10-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2016-11-21 | |
| 1 | 0 | 2016-11-21 |