BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER

    MDR report key: 20434090 · Received October 11, 2024

    Report

    Report Number
    3005168196-2024-00338
    Event Type
    Death
    Date Received
    October 11, 2024
    Date of Event
    September 14, 2024
    Report Date
    October 30, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00815948025943
    PMA / PMN Number
    K211654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1. 3005168196-2024-00339.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS ARE BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY THE PENUMBRA CLINICAL TEAM ON 10/12/2024: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 2. SECTION H. BOX 6. PATIENT CODE 1, 2, AND 3 H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE L M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A DIAGNOSTIC CATHETER (5F), GUIDEWIRES, A CLOSURE DEVICE, AND A SHEATH (8FR) VIA THE RIGHT GROIN. DURING THE PROCEDURE, THE RED72 WAS POSITIONED IN THE PROXIMAL L M1 SEGMENT (PROXIMAL TO THE CLOT) OVER THE SENDIT AND GUIDEWIRE. THE SENDIT AND GUIDEWIRE WERE THEN WITHDRAWN. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED72 INTO THE CLOT; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE CLOT COULD NOT BE REACHED. NEXT, THE RED72 WAS WITHDRAWN INTO THE DISTAL L SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). A ROADMAP ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED NEW OCCLUSION OF THE DISTAL L POSTERIOR COMMUNICATING ARTERY (PCA). THE RED72 WAS ADVANCED TO THE CLOT OVER A GUIDEWIRE INTO THE DISTAL L MCA. TWO PASSES WERE COMPLETED. A CONTROL RUN DEMONSTRATED NEAR-COMPLETE REVASCULARIZATION OF THE L M2 INFERIOR DIVISION WITH PERSISTENT OCCLUSION OF THE L M2 SUPERIOR DIVISION. UNDER ROADMAP ANGIOGRAPHY, A RED68 WAS POSITIONED IN THE L M2 SUPERIOR DIVISION OVER A RED43 AND GUIDEWIRE. THE RED43 AND GUIDEWIRE WERE REMOVED, AND THE RED68 WAS ADVANCED INTO THE CLOT. TWO PASSES WERE COMPLETED. CONTROL RUNS CONFIRMED COMPLETE REVASCULARIZATION WITH THROMBOLYSIS IN CEREBRAL INFARCTION (TICI 2B) WITH FILLING OF BOTH SUPERIOR AND INFERIOR DIVISIONS. IT WAS NOTED THAT A PERFUSION DEFECT IN THE REGION OF PREDICTED CORE AND A SMALL, SUSPECTED, NON-FLOW-LIMITING DISSECTION FLAP IN THE PROXIMAL L M1 SEGMENT (IN THE REGION OF PRIOR RESISTANCE OF THE RED72) AND NEW CLOT OR INJURY IN THE L PCA (PROXIMAL TO THE DISTAL OCCLUSION) WERE CONFIRMED WITH ANGIOGRAPHY. SUBSEQUENT RUNS DEMONSTRATED A WORSENING APPEARANCE OF THE L M1 WITH A SUSPECTED DISSECTION, RE-OCCLUSION OF THE L M2 (SUPERIOR DIVISION), AND COMPLETE OCCLUSION OF THE FETAL L PCA FROM ITS ICA ORIGIN. THE ORIGINAL OCCLUSION SPONTANEOUSLY RECANALIZED ON SUBSEQUENT RUNS. A VASCULAR NEUROLOGIST WAS CONSULTED, AND A DECISION WAS MADE TO PLACE A STENT IN THE L M1 SEGMENT TO THE L SUPRACLINOID ICA. ALTHOUGH THE STENT OPENED THE VESSEL, THE L M1 SEGMENT OCCLUDED COMPLETELY (TICI 0). THE USE OF ANTIPLATELET AGENTS WAS CONSIDERED AND DISCUSSED WITH THE VASCULAR NEUROLOGIST. DUE TO THE SIZE OF THE PATIENT¿S STROKE, THE PHYSICIANS DECIDED TO DEFER ANTIPLATELETS UNTIL REPEAT IMAGING THE NEXT DAY. A DYNACT WAS PERFORMED AND CONFIRMED NO EVIDENCE OF A SIGNIFICANT HEMORRHAGE. THE PROCEDURE ENDED AT THIS POINT. ALL DEVICES WERE REMOVED, AND THE ACCESS SITE WAS SEALED WITH A CLOSURE DEVICE. THERE WERE NO APPARENT PERI-PROCEDURAL COMPLICATIONS, AND THE PATIENT WAS TRANSFERRED TO THE NEURO ICU INTUBATED BUT IN STABLE CONDITION. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2024. ON 27-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT M1 DISSECTION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. ON 27-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED THAT THE NEW THROMBOEMBOLISM TO THE FETAL L PCA WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE L M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A SENDIT DELIVERY DEVICE (SENDIT), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER (RED68), A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), A DIAGNOSTIC CATHETER (5F TEMPO), GUIDEWIRES, A CLOSURE DEVICE AND A SHEATH (8FR) VIA THE RIGHT GROIN. DURING THE PROCEDURE, THE RED72 WAS POSITIONED IN THE PROXIMAL L M1 SEGMENT (PROXIMAL TO THE CLOT) OVER THE SENDIT AND GUIDEWIRE. THE SENDIT AND GUIDEWIRE WERE THEN WITHDRAWN. THE PHYSICIAN ATTEMPTED TO ADVANCE THE RED72 INTO THE CLOT; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE CLOT COULD NOT BE REACHED. NEXT, THE RED72 WAS WITHDRAWN INTO THE DISTAL L SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). A ROADMAP ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED NEW OCCLUSION OF THE DISTAL L POSTERIOR COMMUNICATING ARTERY (PCA). THE RED72 WAS ADVANCED TO THE CLOT OVER A GUIDEWIRE INTO THE DISTAL L MCA. TWO PASSES WERE COMPLETED. A CONTROL RUN DEMONSTRATED NEAR-COMPLETE REVASCULARIZATION OF THE L M2 INFERIOR DIVISION WITH PERSISTENT OCCLUSION OF THE L M2 SUPERIOR DIVISION. UNDER ROADMAP ANGIOGRAPHY, A RED68 WAS POSITIONED IN THE L M2 SUPERIOR DIVISION OVER A RED43 AND GUIDEWIRE. THE RED43 AND GUIDEWIRE WERE REMOVED, AND THE RED68 WAS ADVANCED INTO THE CLOT. TWO PASSES WERE COMPLETED. CONTROL RUNS CONFIRMED COMPLETE REVASCULARIZATION WITH THROMBOLYSIS IN CEREBRAL INFARCTION (TICI 2B) WITH FILLING OF BOTH SUPERIOR AND INFERIOR DIVISIONS. IT WAS NOTED THAT A PERFUSION DEFECT IN THE REGION OF PREDICTED CORE AND A SMALL, SUSPECTED, NON-FLOW-LIMITING DISSECTION FLAP IN THE PROXIMAL L M1 SEGMENT (IN THE REGION OF PRIOR RESISTANCE OF THE RED72) AND NEW CLOT OR INJURY IN THE L PCA (PROXIMAL TO THE DISTAL OCCLUSION) WERE CONFIRMED WITH ANGIOGRAPHY. SUBSEQUENT RUNS DEMONSTRATED A WORSENING APPEARANCE OF THE L M1 WITH A SUSPECTED DISSECTION, RE-OCCLUSION OF THE L M2 (SUPERIOR DIVISION), AND COMPLETE OCCLUSION OF THE FETAL L PCA FROM ITS ICA ORIGIN. THE ORIGINAL OCCLUSION SPONTANEOUSLY RECANALIZED ON SUBSEQUENT RUNS. A VASCULAR NEUROLOGIST WAS CONSULTED, AND A DECISION WAS MADE TO PLACE A STENT IN THE L M1 SEGMENT TO THE L SUPRACLINOID ICA. ALTHOUGH THE STENT OPENED THE VESSEL, THE L M1 SEGMENT OCCLUDED COMPLETELY (TICI 0). THE USE OF ANTIPLATELET AGENTS WAS CONSIDERED AND DISCUSSED WITH THE VASCULAR NEUROLOGIST. DUE TO THE SIZE OF THE PATIENT¿S STROKE, THE PHYSICIANS DECIDED TO DEFER ANTIPLATELETS UNTIL REPEAT IMAGING THE NEXT DAY. A DYNACT WAS PERFORMED AND CONFIRMED NO EVIDENCE OF A SIGNIFICANT HEMORRHAGE. THE PROCEDURE ENDED AT THIS POINT. ALL DEVICES WERE REMOVED, AND THE ACCESS SITE WAS SEALED WITH A CLOSURE DEVICE. THERE WERE NO APPARENT PERI-PROCEDURAL COMPLICATIONS, AND THE PATIENT WAS TRANSFERRED TO THE NEURO ICU INTUBATED BUT IN STABLE CONDITION. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2024. ON 27-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT M1 DISSECTION WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE. ON 27-SEP-2024, ADDITIONAL INFORMATION WAS RECEIVED THAT THE NEW THROMBOEMBOLISM TO THE FETAL L PCA WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. ON 12-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED THAT A 24-HOUR COMPUTED TOMOGRAPHY (CT) REVEALED A LARGE EVOLVING ACUTE LEFT MCA AND PCA TERRITORY INFARCTION WITH CYTOTOXIC EDEMA. THE CEC CHAIR ADJUDICATED EVOLVING ACUTE LEFT MCA AND PCA TERRITORY INFARCTION WITH CYTOTOXIC EDEMA AS A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE INDEX STROKE AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE AND A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM. ON 18-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED THAT THE CEC CHAIR ADJUDICATED THE NEW THROMBOEMBOLISM TO THE FETAL L PCA AS A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDEX STROKE, A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE, AND A POSSIBLE RELATIONSHIP TO THE PENUMBRA SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300722 PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F00011835 00815948025943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death