MAUDE Adverse Event Report: ABIOMED, INC. - 1220648 IMPELLA; INTRODUCER, CATHETER (INTRODUCER)

Catalog Number	0052-3046
Medical Device Problem Codes	Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ischemia (1942); Vascular Dissection (3160)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 72-year-old male with a history of coronary artery disease underwent high-risk percutaneous coronary intervention (hrpci) with pre-support clinical status consistent with scai shock stage d.At the time of the procedure, an intra-aortic balloon pump was present in the left femoral artery.Diagnostic angiography demonstrated vascular access above the femoral bifurcation with severe peripheral artery disease involving the bilateral iliac arteries and a subtotal occlusion of the left superficial femoral artery; timi 3 flow was noted in the profunda femoris, and doppler signals were present in the left dorsalis pedis and posterior tibial arteries.The physician elected to proceed with impella cp support using a single-access technique.Pre-closure was successfully performed over the pre-existing 9 fr sheath using two perclose proglide devices, and the access was upsized to a 14 fr by 13 cm peel-away sheath.Initial advancement of the impella cp was unsuccessful due to left iliac disease, requiring balloon angioplasty and intravascular lithotripsy of the left iliac artery, followed by placement of a covered stent for a dissection.The sheath was then exchanged for a 14 fr by 25 cm sheath, and the impella cp was successfully implanted.The physician chose not to exchange the peel-away sheath for a repositioning sheath to maintain single access.The pci was completed successfully, after which the impella cp was weaned and explanted without issue, and the patient remained hemodynamically stable.Following successful closure of the left femoral artery access site, the patient reported left leg pain and doppler signals were absent in the dorsalis pedis and posterior tibial arteries.Contralateral angiography via the right femoral artery demonstrated timi 1 flow distal to the closure site.The physician proceeded with intervention to the left superficial femoral artery, including balloon angioplasty, drug-coated balloon treatment, and stent placement, after which flow was restored and doppler signals returned.Based on the available information, this event involved difficulty advancing the impella cp through severely diseased vasculature in a patient with known peripheral artery disease and poor distal runoff.Temporary lower extremity ischemia occurred after vascular closure and was managed successfully with additional endovascular intervention.There was no evidence of impella cp device malfunction or damage, and the device functioned as intended throughout use.The reported ischemia may be influenced by patient specific factors such as severe peripheral vascular disease, underlying critical illness, hemodynamic instability, and vascular access characteristics.
Additional Manufacturer Narrative
B5, d4 and h6 have been updated.D4 has been updated accordingly to accurately reflect the appropriate serial number.
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
A 72-year-old male with a history of coronary artery disease underwent high-risk percutaneous coronary intervention (hrpci) with pre-support clinical status consistent with scai shock stage d.At the time of the procedure, an intra-aortic balloon pump was present in the left femoral artery.Diagnostic angiography demonstrated vascular access above the femoral bifurcation with severe peripheral artery disease involving the bilateral iliac arteries and a subtotal occlusion of the left superficial femoral artery; timi 3 flow was noted in the profunda femoris, and doppler signals were present in the left dorsalis pedis and posterior tibial arteries.The physician elected to proceed with impella cp support using a single-access technique.Pre-closure was successfully performed over the pre-existing 9 fr sheath using two perclose proglide devices, and the access was upsized to a 14 fr by 13 cm peel-away sheath.Initial advancement of the impella cp was unsuccessful due to left iliac disease, requiring balloon angioplasty and intravascular lithotripsy of the left iliac artery, followed by placement of a covered stent for a dissection.The sheath was then exchanged for a 14 fr by 25 cm sheath, and the impella cp was successfully implanted.The physician chose not to exchange the peel-away sheath for a repositioning sheath to maintain single access.The pci was completed successfully, after which the impella cp was weaned and explanted without issue, and the patient remained hemodynamically stable.Following successful closure of the left femoral artery access site, the patient reported left leg pain and doppler signals were absent in the dorsalis pedis and posterior tibial arteries.Contralateral angiography via the right femoral artery demonstrated timi 1 flow distal to the closure site.The physician proceeded with intervention to the left superficial femoral artery, including balloon angioplasty, drug-coated balloon treatment, and stent placement, after which flow was restored and doppler signals returned.Based on the available information, this event involved difficulty advancing the impella cp through severely diseased vasculature in a patient with known peripheral artery disease and poor distal runoff.Temporary lower extremity ischemia occurred after vascular closure and was managed successfully with additional endovascular intervention.There was no evidence of impella cp device malfunction or damage, and the device functioned as intended throughout use.The reported ischemia may be influenced by patient specific factors such as severe peripheral vascular disease, underlying critical illness, hemodynamic instability, and vascular access characteristics.

• 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 ; 7814934967
• MDR Report Key: 25080026
• Report Number: 1220648-2026-07460
• Device Sequence Number: 21519483
• Product Code: DYB
• UDI-Device Identifier: 00813502011678
• UDI-Public: (01)00813502011678(17)280630(10)S10012882
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 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): 06/02/2026

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: S10012882
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White