MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA CP; TEMPORARY CARDIAC SUPPORT BLOOD PUMP, PRODUCT CODE: OZD

Model Number IMPELLA CP

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Physical Resistance (2578); Patient-Device Incompatibility (2682)

Patient Problem Blood Loss (2597)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

The investigation of this event included a review of the clinical case and console data, however the pump has not yet been returned for analysis.The console data confirmed the clinical account.The pump primed successfully and provided support for two minutes before the device was stopped by the user.The pump was never turned back on due to the reported issue with the introducer and separated inflow cage.According to the clinical description insertion of the pump was difficult due to the patient's heavily calcified and tortuous vasculature.As listed in the ifu under contraindications: "severe peripheral arterial disease that precludes the placement of an impella cp catheter." as the pci procedure began the sentrant introducer slid out of the artery; requiring repositioning.In order to re-insert the introducer the impella was pulled back through the introducer, however the inflow cage became separated from the catheter at this time.The root cause of the inflow cage separation from the catheter is most likely due to the patient's peripheral vasculature disease, and heavily calcified and tortuous vasculature.The impella cp has not yet been returned for evaluation as it is being held in the facility's risk management department.The manufacturer will continue to investigate all reasonable and obtainable sources of information and will supply results and conclusions in a supplemental medwatch report if the device and/or additional information is received.(b)(4).Product not yet received.

Event Description

An (b)(6) female with a history of peripheral vascular disease, severe microvascular disease, coronary ostial stenosis and chronic total occlusion of the right coronary artery was scheduled for a high-risk pci procedure on (b)(6) 2016.The plan was to implant impella cp for support during the rotational atherectomy portion of the hrpci.Rescue angioplasty with stenting of the left main and left anterior descending was performed.The patient began to decompensate at 5 am and the decision was made to implant impella cp through the right axillary insertion site.A 14 x 28 fr sentrant sheath was inserted with difficulty due to heavy calcified and tortuous vasculature.The vascular surgeon inserted the sheath into the right axillary using ultrasound, and the impella cp was advanced.The pump was started without issue, however when the pci procedure began the sentrant sheath slipped out of the artery.To prepare for repositioning of the device, the pump was pulled back across the valve into the axillary artery to the access site; and the decision was made to reposition the device wirelessly.When the clinical team attempted to pull the pump back into the sheath the pump became lodged in calcium.As the sheath and pump were attempted to be maneuvered around the calcium, the inflow cage separated from the catheter.The separated inflow cage was noted to be securely in the subclavian artery and not in the carotid artery, therefore the decision was made to implant a second impella cp through the left femoral artery in order to complete the pci procedure.The second impella cp was implanted and the pci was successfully completed, however the patient was pulseless throughout the procedure.The clinical team attempted to remove the inflow cage through the right subclavian sheath using a guide wire snare and 5 mm balloon, however they were unsuccessful.A 14 fr introducer was inserted into the right femoral artery where the inflow cage and pigtail were successfully removed.The right femoral insertion site was unable to be successfully closed using a perclose closure device, therefore a covered stent was placed for hemostasis.Throughout the course of the procedure the patient received 4 units of blood products, however it was unclear if the blood replacement was needed due to the pump separation or due to access of the patient's anatomy.The patient was transported to ccu in stable condition and on impella cp support.The patient subsequently expired as a result of multi-system organ failure following 25 hours of successful impella cp support.

Manufacturer Narrative

The investigation of this event included a review of the clinical case and console data that was conducted previously, and the pump has since been returned for evaluation.The pump was returned with the inflow cage separated from the cannula, and the pigtail was deformed and kinked.The cannula is made of a nitinol coil surrounded on both sides by polyurethane.The polyurethane coating had ripped and the nitinol coil had been pulled out of the remaining coating.The bond between the cannula and inflow cage did not fail.There was evidence of a kink right where the polyurethane coating had ripped.(b)(4).

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP, PRODUCT CODE: OZD
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MH 01923
• Manufacturer Contact: william bolt ; 22 cherry hill drive; danvers, MA 01923
• MDR Report Key: 6260115
• MDR Text Key: 65059913
• Report Number: 1220648-2017-00005
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1400003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1258949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THE 14 X 28 FR SENTRANT SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR