MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE068KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the patient underwent a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and other devices.There were no procedural complications reported.On (b)(6) 2023, the patient experienced disorientation and a slight left hemiparesis.The mri detected a suspected foreign body granulomas along the cortical border, which were found in the anterior cerebral artery (aca) and the anterior communication artery (acom).There was also edema noted.The physician then started a cortisone therapy.It was reported that the patient expired on (b)(6) 2023 due to a heart attack.The foreign body reaction was reported to have a possible relationship to the ace68.
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.Infection is included as a possible complication in the instructions for use (ifu) for the penumbra system.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the federal institute for drugs and medical devices (bundesinstitut für arzneimittel und medizinprodukte, bfarm) on (b)(6) 2023: 1.Section a.Box 2.Age at time of event/age unit.2.Section a.Box 2.Date of birth: should be left blank.3.Section b.Box 5.Describe event or problem.4.Section d.Box 4.Lot number, catalog number, expiration date, unique identifier.5.Section h.Box 4.Device manufacture date.6.Section h.Box 6.Evaluation codes: method code 3.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Event or Problem Description
On (b)(6) 2023, the patient underwent a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f (6f select), a non-penumbra microcatheter, stent retrievers, and guidewires.It was noted that the patient had a severe cardiac illness and presented with severe left hemiparesis and dysarthria.At the time of discharge, the patient had mild hemiparesis.The computed tomography (ct) scan revealed a partial infarction of the right truncal ganglion.There were no procedural complications reported.On (b)(6) 2023, the patient was readmitted after a first bilateral tonic clonic seizure.The mri revealed an image finding that is described in publications with cerebral granulomas as a reaction to embolized hydrophilic polymers from microwires, microcatheters or aspiration catheters.The suspected foreign body granulomas along the cortical border were found in the anterior cerebral artery (aca) and the anterior communication artery (acom).There was also edema noted.The physician then started methylprednisolone therapy which led to significant clinical improvement.On imaging, the changes were subtotal regression.It was reported that the patient expired on (b)(6) 2023 due to a heart attack.The foreign body reaction was reported to have a possible relationship to the ace68.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• 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: 17731903
• Report Number: 3005168196-2023-00425
• Device Sequence Number: 12295904
• Product Code: NRY
• UDI-Device Identifier: 00815948022850
• UDI-Public: 815948022850
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023
• 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: 02/13/2025
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: C00009245
• 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: 08/15/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2014
• 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: 83 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005