MAUDE Adverse Event Report: ABIOMED, INC IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number	IMPELLA CP
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Hematoma (1884); Blood Loss (2597)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The evaluation confirmed that both the desivalve, repo 9f (part number 0046-0552) and tapered wound closure 15f (part number 0046-0517) were found to be damaged.Both parts were found to have multiple cracks at their tips and were scratched in the areas behind cracks.This damage is consistent with damage that usually caused by calcified vasculature; however, according to the complainant no calcifications were visualized during this case.A manufacturing review was done, which revealed that there were no material review reports or reworks that apply to this failure mode.In addition, a review of the device history record was performed and it did not reveal any complaints against this lot of impella cp pumps.In conclusion the root cause of the access site hematoma was a damaged repositioning unit.The damage to the repositioning unit has been confirmed, but the root cause was unable to be determined.No corrective action is recommended because the root cause was unable to be determined.(b)(4).
Event or Problem Description
On (b)(6) 2017 an impella cp was inserted in the left groin of a (b)(6) male patient.The pump was placed without issue.The patient was then removed from the cath lab and was taken to the operating room for by-pass surgery.At this time it was noticed that the pump flows and pressures were dropping.A hematoma was found in the patient's groin.Manual pressure was held.It was then observed that blood was actually coming from the repositioning sheath, which was found to be cracked.A cut-down procedure was performed and proximal and distal purse string were applied to the femoral artery.The repositioning sheath was removed from the artery, while the impella cp remained in the patient.A three vessel cabg was successfully performed.The impella cp was sutured to the patient's groin, with a plan to leave the pump in the patient's for a couple of days.Pulses were palpable in the affective groin, and the site was reported to look much better with no hematoma, and the area was soft but was much bruised.The impella was removed from the patient on (b)(6) 2017, after 54.98 hours of successful patient support.The physician reported that he was very happy with the patient's recovery and how well he did with the impella cp support.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7205913
• Report Number: 1220648-2017-00129
• Device Sequence Number: 1486265
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1273798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR