MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Model Number	LITNG12HTORQ115-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Cardiac Arrest (1762)
Date of Event	09/02/2022
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2022, the patient underwent a medical procedure using an indigo aspiration system.On (b)(6) 2022, the patient's baseline hemoglobin decreased, and the patient received a transfusion to keep hemoglobin greater than 7.The same day, the hemoglobin at baseline dropped further to 2.15.Anemia and worsening anemia were reported to be adverse events with a possible relationship to the indigo aspiration system and a possible relationship to the index procedure and is unresolved.On (b)(6) 2022, the site reported patient expired on (b)(6) 2022.Massive recurrent pulmonary embolus was reported as the cause of death and was not related to the indigo aspiration system.On (b)(6) 2022, the investigator reassessed the anemia and worsening anemia relationship to indigo device from possibly related to unrelated.On (b)(6) 2023, the independent medical reviewer (imr) re-adjudicated the recurrent pulmonary embolus from unrelated to probably related to the index procedure and the indigo aspiration system.On (b)(6) 2023, an update was received indicating right ventricular (rv) failure and cardiovascular collapse after recurrent pulmonary embolus.The imr adjudicated the rv failure and cardiovascular collapse to be possibly related to the indigo aspiration system.Recurrent clinical pulmonary embolism (pe) was noted post embolectomy with hypotension and deterioration.Distal embolization of more proximal thrombus was suspected and the thrombectomy did not clear enough thrombus.It was reported that there was concern for bleeding that could have also contributed to the instability.Patient deteriorated with shock and expired.
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported events.Emboli and death, are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
Please note that the following sections were updated: 1.Section h.Box 6.Evaluation codes.Patient code 1.2.Section h.Box 10./11.Additional narrative and/or corrected data.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported events.Cardio-respiratory arrest and death, are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16456846
• Report Number: 3005168196-2023-00092
• Device Sequence Number: 11348705
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 00815948022577
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024
• Report Date (Section F): 01/01/2005

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 Expiration Date: 02/03/2025
• Device Model Number: LITNG12HTORQ115-A
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H12512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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: Death
• Patient Age: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005