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

Catalog Number 5MAXACE068KIT

Device Problem Entrapment of Device (1212)

Patient Problems Intracranial Hemorrhage (1891); Vasoconstriction (2126); Hemorrhagic Stroke (4417); Embolism/Embolus (4438)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the labeling with the penumbra system include, but are not limited to hematoma or hemorrhage at access site, emboli, air embolism, distal embolization, inability to completely remove thrombus, vessel spasm, intracranial hemorrhage, thrombosis, dissection, or perforation.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

The date of event occurred over 1 year ago (2020).The date of event and the date of when the additional procedure was performed are unknown.The patient was undergoing a thrombectomy procedure in the m2 superior trunk and the m3 region of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra stent retriever, and a non-penumbra balloon catheter.During the procedure, the physician deployed the stent retriever at the distal end of the m2 superior trunk and then while attempting to pull the stent retriever into the ace68, it became stuck.Therefore, the ace68 and the stent retriever were removed together.Subsequently, a distal embolus occurred in the m3 region.Next, the physician removed and recovered the distal embolus in the m3 region by using the stent retriever, the balloon catheter and ace68.Subsequently, it was reported that the patient¿s blood vessel was stressed upon removal of the stent retriever and ace68 from the patient¿s body.The procedure ended with complete recanalization achieved and a mild spasm that was noted in the mca.It was also reported that a subarachnoid hemorrhage, and left hemiplegia was noted post-procedure that was addressed with an additional procedure.No further information was provided.

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.1.Section b.Box 5.Describe event or problem, 2.Section h.Box 6.Patient code 1 & patient code 3.

Event Description

The date of event and the date of when the additional procedure was performed are unknown.The patient was undergoing a thrombectomy procedure in the m2 superior trunk and the m3 region of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra stent retriever, and a non-penumbra balloon catheter.During the procedure, the physician deployed the stent retriever at the distal end of the m2 superior trunk and then while attempting to pull the stent retriever into the ace68, it became stuck.Therefore, the ace68 and the stent retriever were removed together.The physician readvanced the stent retriever, balloon catheter and ace68 to remove additional emboli in the m3 region.Subsequently, it was reported that the patient¿s blood vessel was stressed upon removal of the stent retriever and ace68 from the patient¿s body.The procedure ended with complete recanalization achieved and a mild spasm that was noted in the mca.It was also reported that a subarachnoid hemorrhage, and left hemiplegia was noted post-procedure that was addressed with an additional procedure.No further information was provided.

• 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: 12776029
• MDR Text Key: 280511434
• Report Number: 3005168196-2021-02517
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K161640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5MAXACE068KIT
• 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
• Date Manufacturer Received: 01/14/2005
• 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): Required Intervention