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

Model Number IMPELLA CP

Device Problems Difficult or Delayed Positioning (1157); Device Issue (2379); Patient-Device Incompatibility (2682)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

The device has been returned for evaluation.The automatic lmpella controller data logs have not yet been received for the analysis to be performed in conjunction with the lmpella cp evaluation.Upon the return of the automatic lmpella controller data logs the analysis and evaluation will be performed.Upon completion a supplemental medwatch report containing the results and conclusions will be submitted.(b)(4).

Event Description

Complainant reported that during transfer from one sister hospital to another a (b)(6) morbidly obese female patient required advanced cardiac life support (acls), which entailed 5 defibrillations.Upon entry into the second hospital on (b)(6) 2016 the patient was diagnosed with an acute myocardial infarction (ami) and was in cardiogenic shock (cgs.) an angiogram was performed which revealed a clot in the left anterior descending artery.A peripheral thrombectomy was performed with an angiojet and one 4.0 bare metal stent was placed without issue.The physician attempted to place an lmpella cp via access through the left femoral artery (lfa) while another physician worked on the patient's coronary arteries.It was discovered during this emergent treatment that the patient's profunda was actually accessed, not the lfa.The physician stated that the patient's obesity played a role in accessing the arteries and coronaries.As the 14fr oscor sheath was peeled away and as the repositioning sheath was advanced the physician continued to encounter issues advancing the repositioning sheath.And found that the sheath would not advance.The physician stated that the issues with advancing the sheath were as a result of the patient's extreme obesity.Upon the removal of the repositioning it was found that the sheath was peeled away and was shredded at the tip.The physician went contralateral and performed an angiogram to the lfa and the superficial femoral artery (sfa) and found that the profunda had been perforated.The team performed a contralateral tamponade to control bleeding, and then they tacked up the perforated profunda with 2 icast stents.No replacement blood products were needed to be administered to the patient.The patient continued to be administered norepinephrine.The team elected not to replace the lmpella cp as the patient's pressures had improved.

Manufacturer Narrative

The lmpella cp was returned for evaluation.The automatic lmpella controller data logs were also returned.The analysis of the data logs showed normal patient support for over 3 hours.The evaluation of the returned repositioning sheath revealed a large amount of tearing on the sheath, as well as a bent tip on the sheath.The damage observed to the sheath was most likely the result of patient's morbidly obese condition, also confirmed by the physician's report that sheath access was difficult because of the paitent's size.The perforation of the profunda most likely occurred while the physician was attempting to advance the repositioning sheath.The root cause of the split repositioning sheath was the patient's obese condition.The root cause of the patient's perforated profunda was the physician's attempt to advance the repostioning sheath despite the split in the sheath.A corrective action has been initiated to address this failure mode.The abiomed directions for use for the impella cp gives the following alert regarding the use of the device with an obese patient: when securing the repositioning sheath, vascular closure may be difficult in obese patients with extensive adipose tissue.Internal reference: (b)(4).

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: william bolt ; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 6120616
• MDR Text Key: 60658745
• Report Number: 1220648-2016-00033
• 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: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 103737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2016
• 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: ANGIOJET PERIPHERAL THROMBECTOMY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR