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

Model Number	LITNG12XTORQ100-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, hematoma, hemorrhage, or blood loss at access site, hematoma, hemorrhage, or blood loss, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2021, the patient underwent a thrombectomy procedure in the right popliteal vein, common femoral vein, and external and common iliac veins using a penumbra engine (engine), an indigo system cat12 aspiration catheter (cat12) with lightning aspiration tubing (lightning), an indigo system separator 12 (sep12), non-penumbra catheters, and a non-penumbra stent with an excessive blood loss (ebl) of 500 ml.Post procedure, on (b)(6) 2021, the physician performed another thrombectomy procedure on the patient for re-thrombosis which resulted with ebl of 550 ml.On (b)(6) 2021, patient received two units packed red blood cells.It was reported that the patient¿s hgb decreased to 6.6 g/dl.On (b)(6) 2021, patient was discharged home in stable condition.The anemia was reported to be serious adverse event with a possible relationship to the indigo system and index procedure.
Event or Problem Description
On (b)(6) 2021, the patient underwent a thrombectomy procedure in the right popliteal vein, common femoral vein, and external and common iliac veins using a penumbra engine (engine), an indigo system cat12 aspiration catheter (cat12) with lightning aspiration tubing (lightning), an indigo system separator 12 (sep12), non-penumbra catheters, and a non-penumbra stent with an excessive blood loss (ebl) of 500 ml.Post procedure, on (b)(6) 2021, the physician performed another thrombectomy procedure on the patient for re-thrombosis which resulted with ebl of 550 ml.On (b)(6) 2021, patient received two units packed red blood cells.It was reported that the patient¿s hgb decreased to 6.6 g/dl.On (b)(6) 2021, patient was discharged home in stable condition.The anemia was reported to be serious adverse event with a possible relationship to the indigo system and index procedure.On (b)(6) 2022, the clinical events committee (cec) chair adjudicated the anemia to be an adverse event with a possible relationship to the indigo system and unrelated relationship to the index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the clinical events committee (cec) on 25-sep-2024.

• 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: 12797338
• Report Number: 3005168196-2021-02554
• Device Sequence Number: 5588718
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 00815948022560
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024
• 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: 03/17/2024
• Device Model Number: LITNG12XTORQ100-A
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: F104690
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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
• Patient Age: 41 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005