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

Catalog Number	0052-3005
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complainant reported a patient on impella support with a cp pump.The complainant reported the following: short impella sheet inserted pigtail crust, aortic valve and a left ventricle impella on a wire inserted catheter removed impella cp inserted on wire in, advanced through the iliac, where the physician had to push a little bit it continued up until the descending aortic arch where the physician met extreme resistance, ended up visualizing the end of the sheath and saw the wire and catheter buckling.Staff then stopped remove the impeller from the short impeller sheath, flush the catheter and prepared it for reinsertion and then the long impella 14 french sheet was inserted pigtail advanced cross the aortic valve again this time with a v8 wire.The impella was then re-advanced to the sheath in advanced no issues through the iliac artery, but then when it got back to the descending arch, had difficulties crossing as well lost wire in the left ventricle.Then explained the impella ref flushed the device again and then we attempted with a third time with a third new wire and we inserted the impala and brought it just distal to where we were having issues in the arch.Staff then used a single access technique and put a hand flat super stiff wire in advanced that super stiff wire up and around the arch to give buddy wire technique to help support the impella advancing, and that attempt did not help either no buckling was noted anywhere in the distal end of the catheter while trying to insert the impeller.The physician decided to explant everything and take a picture of coronary arteries.And each french guide cath was inserted and was taken and decision made to stop an explant the impella sheets and give patient new options and potentially plan for an actually cut down or axillary cp case at a later date.
Additional Manufacturer Narrative
The impella device has not been received from the customer.Therefore, investigation of the device is not possible.Should the device or any new information be received, a supplemental mdr will be filed.
Additional Manufacturer Narrative
H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation and added clinical review.The cause of pd-any device-(twist, bent, kinked) was unable to be determined as limited clinical details were provided and no product was returned for review.

• Brand Name: IMPELLA
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; 7814934967
• MDR Report Key: 24933686
• Report Number: 1220648-2026-06987
• Device Sequence Number: 16119922
• Product Code: OZD
• UDI-Device Identifier: 04260113630303
• UDI-Public: (01)04260113630303(17)280430(10)9464337
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3005
• Device Lot Number: LN 9464337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: White