MAUDE Adverse Event Report: Abiomed, Inc. - 1220648 Impella; Introducer, Catheter (Introducer)

Catalog Number	0052-3046
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	08/21/2026
Type of Reportable Event	Death
Event or Problem Description
Impella cp was inserted via the left femoral artery in a 61-year-old female patient for an unknown indication.The patient's comorbidities were not reported.The patient's clinical presentation included out-of-hospital cardiac arrest.The patient's clinical state prior to initiation of support was society for cardiovascular angiography and interventions (scai) shock stage e, identified as refractory shock with actual or impending circulatory collapse when the body fails to respond to maximal life-saving therapies, leading to full organ shutdown.Upon initiation of impella support, the patient was receiving inotrope therapy, vasopressor therapy, and respiratory support.Following insertion, the 14 french sheath was left in place and the patient was transferred to the intensive care unit (icu).It was reported the patient required continued administration of vasoconstrictive medication, despite the addition of impella support.While in the icu, diminished distal pulses in the left lower extremity were reported.A distal limb perfusion (dlp) catheter was placed the following day, resulting in restoration of distal perfusion.Anticoagulation monitoring was performed using partial thromboplastin time (ptt) testing, with a reported value of 194 seconds; however, it is uncertain how the reported ptt correlates to abiomed's recommended activated clotting time maintenance range of 160 to 180 seconds during support.A serum lactate laboratory test was reported as 11.1mmol/l at initiation of support and remained elevated three days later, with a repeat value of 4.9mmol/l, indicating persistent critical illness.The patient subsequently expired after approximately three days on support.At the time of the reported limb ischemia, the impella cp was operating as intended at performance level p9 with flows of 3.4 l/min.The purge solution contained 5% dextrose in water with sodium bicarbonate.The reported peripheral artery ischemia is a procedural complication associated with arterial access and was contributed to by retention of the 14 french peel-away introducer sheath beyond the procedural setting; which is contraindicated in instructions for use recommended best practices.The ongoing requirement for vasoconstrictive medications also contributed to the reduced peripheral blood flow.The patient's death is attributable to the severity of the presenting clinical condition, including out-of-hospital cardiac arrest, persistent elevation of serum lactate indicating ongoing shock despite continuous multimodal interventions.The death is not felt to be associated to the impella device as the limb ischemia resolved with the placement of the perfusion catheter and the patient remained on support for 3 days with the device functioning as expected.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by abiomed inc or its employees that the report constitutes an admission that the product, abiomed inc, or its employees, caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: Impella
• Common Device Name: Introducer, Catheter (Introducer)
• Manufacturer (Section D): Abiomed, Inc. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill drive; danvers, MA 01923 ; +1(781)493-4967
• MDR Report Key: 50519108
• Report Number: 1220648-2026-12237
• Device Sequence Number: 9521826
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)290731(10)S10914047
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10914047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Supplement Date Received by Manufacturer: 08/23/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 187 LB
• Patient Race: White