MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 7; QEW

Catalog Number	LITNG7XTORQ130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ischemia is included as possible complication in the instructions for use (ifu) for the indigo aspiration system.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
On (b)(6) 2022, the patient underwent a thrombectomy procedure in the superficial femoral artery, popliteal artery, tibioperoneal trunk, and popliteal stent graft using an indigo system aspiration catheter 7 (cat7), a lightning aspiration tubing (lightning), and a penumbra engine (engine).During the procedure, the physician completed 20 passes using the cat7 and lightning.Following the procedure, an angiography was performed and showed 50%-99% stenosis in the distal popliteal artery.On (b)(6) 2022, the patient¿s left lower extremities pulse signals diminished.An angiography and balloon angioplasty of the left superficial femoral artery and left popliteal artery was performed, and the patient was treated with a continuation of thrombolysis.On (b)(6) 2022, an angiography was performed in the left lower extremities followed by a termination of thrombolysis.On (b)(6) 2022, amputations of the left second toe at the proximal phalangeal bone and of the left great toe at the proximal interphalangeal bone were performed.On (b)(6) 2022, a left sfa and popliteal bypass was performed with a recurrent varicose vein of the great saphenous vein (rgsv) from the left lower extremity.An angiogram of the left lower extremity was then completed.On (b)(6) 2022, a transmetatarsal amputation was performed in the left lower extremity.Subsequently, negative pressure wound therapy was applied to the left transmetatarsal amputation site.The worsening ischemia was reported to be a serious adverse event with a possible relationship to the indigo aspiration system and a definite relationship to the index procedure.The event was considered resolved on (b)(6) 2022.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 08/15/2022: 1.Section b.Box 5.Describe event or problem.Note: the worsening ischemia was previously adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the cat 7.However, on (b)(6) 2022, it was adjudicated that the worsening is unrelated to the cat 7.Therefore, this event is not considered reportable against the cat7.
Event or Problem Description
On (b)(6) 2022, the patient underwent a thrombectomy procedure in the superficial femoral artery, popliteal artery, tibioperoneal trunk, and popliteal stent graft using an indigo system aspiration catheter 7 (cat7), a lightning aspiration tubing (lightning), and a penumbra engine (engine).During the procedure, the physician completed 20 passes using the cat7 and lightning.Following the procedure, an angiography was performed and showed 50%-99% stenosis in the distal popliteal artery.On (b)(6) 2022, the patient¿s left lower extremities pulse signals diminished.An angiography and balloon angioplasty of the left superficial femoral artery and left popliteal artery was performed, and the patient was treated with a continuation of thrombolysis.On (b)(6) 2022, an angiography was performed in the left lower extremities followed by a termination of thrombolysis.On (b)(6) 2022, amputations of the left second toe at the proximal phalangeal bone and of the left great toe at the proximal interphalangeal bone were performed.On (b)(6) 2022, a left sfa and popliteal bypass was performed with a recurrent varicose vein of the great saphenous vein (rgsv) from the left lower extremity.An angiogram of the left lower extremity was then completed.On (b)(6) 2022, a tarsometatarsal amputation was performed in the left lower extremity.Subsequently, negative pressure wound therapy was applied to the left tarsometatarsal amputation site.The worsening ischemia was reported to be a serious adverse event with a possible relationship to the indigo aspiration system and a definite relationship to the index procedure.The event was considered resolved on (b)(6) 2022.On 15-aug-2022, we received an update indicating that the site determined the worsening ischemia was unrelated to the indigo aspiration system and to the index procedure.

• Brand Name: INDIGO SYSTEM LIGHTNING 7
• 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: 15222668
• Report Number: 3005168196-2022-00375
• Device Sequence Number: 15125487
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 815948022584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210083
• 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): 09/15/2022
• 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 Catalogue Number: LITNG7XTORQ130
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/13/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005