MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 8; QEW

Model Number	LITNG8XTORQ115-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/29/2021
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, distal embolization, hematoma or hemorrhage at the site, inability to completely remove thrombus, 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 popliteal artery using an indigo system aspiration catheter 8 (cat8).It was reported the patient had previous intervention on the affected limb, and there were no reported complications during the procedure.The post-treatment angiogram showed a small amount of thrombus that was noted in the distal plantar arch.There was no flow beyond the thrombus, and no intervention was done.The event was resolved the same day.The peripheral/ distal embolism was reported to be a non-serious adverse event with a possible relationship to the cat8 and the index procedure.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2021-01291 1.Section d.Box 1.Brand name.2.Section g.Box 5.510 (k).Please note that the following section is being updated based on additional information provided by the penumbra clinical team on 08 feb 23: 1.Section b.Box 5.Describe event or problem.Note: the peripheral/ distal embolism was previously adjudicated to be a non-serious adverse event with a possible relationship to the index procedure and a possible relationship to the indigo system aspiration catheter 8 (cat8).However, on 08 feb 23, an update was received from the clinical team reporting that the small amount of thrombus noted in the distal plantar arch was a chronic occlusion, not a new distal embolization.Therefore, this event is not considered reportable against the cat8.
Event or Problem Description
On (b)(6) 2021, the patient underwent a thrombectomy procedure in the popliteal artery using an indigo system aspiration catheter 8 (cat8).It was reported the patient had previous intervention on the affected limb, and there were no reported complications during the procedure.The post-treatment angiogram showed a small amount of thrombus that was noted in the distal plantar arch.There was no flow beyond the thrombus, and no intervention was done.The event was resolved the same day.The peripheral/ distal embolism was reported to be a non-serious adverse event with a possible relationship to the cat8 and the index procedure.On 08 feb 23, an update was received from the clinical team reporting that the small amount of thrombus noted in the distal plantar arch was a chronic occlusion, not a new distal embolization.

• Brand Name: INDIGO SYSTEM LIGHTNING 8
• 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: 11971277
• Report Number: 3005168196-2021-01291
• Device Sequence Number: 4229422
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 03/08/2023
• 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: 08/11/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10690
• 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: 05/12/2021
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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: Other
• Patient Age: 41 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005