MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE; NRY

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

Patient Problem Vascular Dissection (3160)

Event Date 02/22/2019

Event Type  Injury  

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 labeling with the penumbra system include, but are not limited to, vessel spasm, thrombosis, dissection, or perforation, including death.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra 3d revascularization device (psr3d), a penumbra system ace 68 reperfusion catheter (ace68), a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and a non-penumbra catheter.During the procedure, the physician completed the first pass using the neuron max and the ace68, resulting in a modified treatment in cerebral infarction (mtici) score of 0.The second pass was completed using the ace68, the psr3d, and the microcatheter, resulting in a mtici score of 1.The third pass was made using the ace68 and the psr3d, resulting in a mtici score of 0.Subsequently, the principal investigator (pi) noted new thrombus on the digital subtraction angiography (dsa) imaging, which was likely due to an intima injury and was reported as a vessel dissection.The procedure was completed using three additional passes and tirofiban, a thrombolytic agent.The indeterminate vessel dissection was resolved on the same day.On (b)(6) 2021, a follow-up dsa was normal and showed no sign of dissection.On (b)(6) 2019, the patient was discharged home with a modified rankin scale (mrs) score of 0.No other adverse events were reported.The indeterminate vessel dissection was adjudicated to be non-serious adverse event related to the psr3d and the index procedure and unrelated to all other devices.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• 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: 11519557
• MDR Text Key: 240963119
• Report Number: 3005168196-2021-00529
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K190464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,02/19/2021

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: 02/19/2021
• Initial Date FDA Received: 03/18/2021
• 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: 46 YR