MAUDE Adverse Event Report: ABIOMED EUROPE GMBH IMPELLA CP; TEMPORARY NON-ROLLER LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problems Kinked (1339); Patient-Device Incompatibility (2682); Human-Device Interface Problem (2949); Torn Material (3024)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The 14 fr x 25 cm introducer was returned for device analysis.The impella cp and data logs were not returned for this investigation.The introducer was measured and found to be within specifications.The introducer was found to have 2 kinks, as the clinical report had mentioned.In addition there was damage noted at the tip of the introducer as well.The root cause of the vascular damage and associated bleed, was a tear at the tip of the introducer sheath.No corrective action is warranted at this time, as the failure mode was determined to be low risk.The failure mode will be monitored and trended.(b)(4).

Event Description

A (b)(6) male with known 3 vessel coronary artery disease and peripheral vascular disease, presenting with bilaterally occluded iliacs, was taken to the cardiac catheterization lab for insertion of the impella cp and angioplasty of 3 coronary arteries.The impella cp was placed through a 14fr introducer that kinked at insertion into the axillary artery.The cp supported the patient successfully for the angioplasty procedure and was then explanted.After the introducer was explanted a perclose was placed and protamine was given to reverse the anticoagulation.The patient had a re-bleed at the axillary site and had a vagal episode in the recovery room.The team gave the patient two units of blood and iv fluids and he was reported as stable and doing well.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen, 52074 ; GM 52074
• Manufacturer (Section G): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 7288543
• MDR Text Key: 100667594
• Report Number: 1220648-2018-00008
• Device Sequence Number: 1
• Product Code: OZD
• 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
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0020
• Device Lot Number: 1320825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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: PERCLOSE; PROTAMINE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR