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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhagic Stroke (4417)

Event Date 01/01/2018

Event Type  Injury  

Event Description

During its post-market surveillance activities on 31-may-2022, penumbra inc.Became aware of a journal article titled, "safety and efficacy of mechanical thrombectomy using tigertriever as a rescue device after failed aspiration¿single center experience" (piasecki et al.2020).In this retrospective review, twenty patients underwent thrombectomy procedures between january 2018 and march 2020 using a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max) to make passes using the direct aspiration first pass technique (adapt).However, after three unsuccessful passes, the patients were treated with a non-penumbra device (tigertriever).One patient who underwent a thrombectomy procedure for a carotid t occlusion and received the full dose of tissue plasminogen activator (rtpa) was treated using the ace68 to perform the adapt technique.After three unsuccessful passes with the ace68, the physician used the tigertriever to successfully complete the procedure.There were no significant technical difficulties with the ace68.However, control computed tomography scan (ct) revealed a subarachnoid hemorrhage, hi-2 in the middle cerebral artery (mca) vascular region.It was reported that the most probable cause of sah was damage to small perforators located in this area during traction.The relationship between the ace68 and the subarachnoid hemorrhage was not specified.It was also reported that the patient expired six days later due to acquired massive pneumonia.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

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 penumbra system instructions for use (ifu) include, but are not limited to, hematoma or hemorrhage at access site, inability to completely remove thrombus, neurological deficits including stroke, intracranial hemorrhage, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on 31-may-2022, penumbra inc.Became aware of a journal article titled, "safety and efficacy of mechanical thrombectomy using tigertriever as a rescue device after failed aspiration¿single center experience" (piasecki et al.2020).In this retrospective review, twenty patients underwent thrombectomy procedures between january 2018 and march 2020 using a penumbra system ace 68 reperfusion catheter (ace68) and a neuron max 6f 088 long sheath (neuron max) to make passes using the direct aspiration first pass technique (adapt).However, after three unsuccessful passes, the patients were treated with a non-penumbra device (tigertriever).One patient who underwent a thrombectomy procedure for a carotid t occlusion and received the full dose of tissue plasminogen activator (rtpa) was treated using the ace68 to perform the adapt technique.After three unsuccessful passes with the ace68, the physician used the tigertriever to successfully complete the procedure.There were no significant technical difficulties with the ace68.However, control computed tomography scan (ct) revealed a subarachnoid hemorrhage, hemorrhagic infarction (hi-2) in the middle cerebral artery (mca) vascular region.It was reported that the most probable cause of sah was damage to small perforators located in this area during traction.The relationship between the ace68 and the subarachnoid hemorrhage was not specified.It was also reported that the patient expired six days later due to acquired massive pneumonia.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

Manufacturer Narrative

Please note that the complete name of the abbreviation was inadvertently left out of the following sentence reported under section b.Box 5.Describe event or problem of the initial mfr report: "however, control computed tomography scan (ct) revealed a subarachnoid hemorrhage, hi-2 in the middle cerebral artery (mca) vascular region." the sentence above should have read: "however, control computed tomography scan (ct) revealed a subarachnoid hemorrhage, hemorrhagic infarction (hi-2) in the middle cerebral artery (mca) vascular region.¿ h3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Type of Device: 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: 14667212
• MDR Text Key: 294596406
• Report Number: 3005168196-2022-00278
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/21/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/11/2022
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female