MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 KIT, 14FR INTRODUCER, 13CM&25CM, STERILE; INTRODUCER, CATHETER (SHEATH)

Catalog Number	0052-3046
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
An impella cp device was inserted via the right femoral artery in an 87-year-old male patient who presented for high-risk percutaneous coronary intervention (hrpci).The patient¿s medical history was significant for coronary artery disease with multi-vessel involvement and cardiopulmonary resuscitation.The patient had a reported lactate of 5.2 millimoles per liter and was receiving amiodarone and vasopressor/inotropic therapy.The patient was additionally supported with veno-arterial extracorporeal membrane oxygenation (va-ecmo).The patient¿s clinical state prior to initiation of support was initially reported as scai shock stage a; however, based on the presence of elevated lactate, the requirement for vasoactive therapy, and the need for concomitant mechanical circulatory support, the clinical presentation is more consistent with scai shock stage e.Following impella cp insertion, decreased perfusion to the access limb was reported.It was also noted that the 14 french peel-away sheath was left in place post-implantation, which is outside of recommended use and may increase the risk of access site-related adverse events, including compromised distal limb perfusion.The impella cp was reported to be functioning at performance level p-4 with flows of approximately 2.2 liters per minute.The purge solution consisted of dextrose 5% with 25 milliequivalents sodium bicarbonate, infusing at 16.2 milliliters per hour with a purge pressure of 423 millimeters of mercury.Device performance was reported to be within expected operating parameters during support.After approximately 29 hours of combined impella cp and va-ecmo, the impella cp device was removed and mechanical circulatory support was escalated to an impella 5.5 device with continuation of va-ecmo.Decreased limb perfusion is a known potential complication associated with large-bore arterial access and may be multifactorial in origin, including the patient¿s underlying critical illness, vasopressor use, and access-related factors.Based on the reported information, no device malfunction was identified, and the impella cp functioned as intended.Therefore, the clinical events described are most likely attributable to the patient¿s underlying clinical condition and procedural/access-related factors rather than a malfunction of the impella cp device.The post-procedure patient outcome remains ongoing at the time of this report.
Additional Manufacturer Narrative
Corrected information was provided in d3 (manufacturer fax), d10 (concomitant).Upon review, it was identified that it was inadvertently omitted from the initial report.H6: updated codes based on the results of the investigation.H11: updated based on the results of the investigation.The cause of the injury was not determined due to insufficient clinical details.

• Brand Name: KIT, 14FR INTRODUCER, 13CM&25CM, STERILE
• Common Device Name: INTRODUCER, CATHETER (SHEATH)
• Manufacturer (Section D): ABIOMED, INC. - 1220648; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: derek sammarco ; 22 cherry hill dr.; danvers, MA 01923 ; 7814934967
• MDR Report Key: 25429949
• Report Number: 1220648-2026-08590
• Device Sequence Number: 21356079
• Product Code: DYB
• UDI-Device Identifier: 00813502013474
• UDI-Public: (01)00813502013474(17)280731(10)S10066988
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/08/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0052-3046
• Device Lot Number: S10066988
• 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: 06/03/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VA-ECMO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White