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

Catalog Number PSR3D

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

Patient Problem Intimal Dissection (1333)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01864.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet 7 kit and a penumbra system 3d revascularization device (psr3d).It should be noted that the embolus was very calcified.During the procedure, the physician advanced the psr3d up to the target location through a penumbra system jet 7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max), then used the psr3d to engage the thrombus.While attempting to retract the psr3d, the physician encountered resistance and the psr3d was stuck on the embolus.Therefore, the physician attempted to advance the jet7 over the pull wire of the psr3d to recapture the psr3d; however, resistance was encountered.The physician then pulled on the psr3d until it released.However, when pulling on the psr3d to release it, some intima of the artery was torn off where the psr3d was stuck on the clot.The jet7, psr3d, and neuron max were therefore removed together from the patient.After the jet7 was removed from the patient and inspected on the back table, the physician noted that it was accordioned on the distal 30 cm location.The procedure was then continued using another jet7, the same neuron max, and a stent retriever.However, the embolus was not able to be removed using any device and the procedure was ended.

Manufacturer Narrative

Results: the psr3d was kinked approximately 4.0, 195.0, and 197.0 from the proximal end.Conclusions: evaluation of the returned jet7 revealed that the catheter was kinked.This damage likely occurred due to forcefully advancing the device against the resistance experienced during the procedure.Tortuous or difficult anatomy may have contributed to the resistance and damage on the returned device.Evaluation of the returned psr3d revealed that the device was kinked on the distal delivery wire.Based on the location and shape, tortuous anatomy likely contributed to the distal delivery wire damage.During the functional test, the returned psr3d was delivered to the tip of the returned jet7 through a demonstration 3max.Resistance was experienced advancing the psr3d likely due to the distal delivery wire damage.The 3maxc with the psr3d were retracted through the returned jet7 without issue.The neuron max identified in the complaint was not returned for evaluation.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra stents are visually inspected during in-process inspection and during quality inspection after manufacturing.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: 3005168196-2019-01864.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9152404
• MDR Text Key: 161185286
• Report Number: 3005168196-2019-01865
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948020900
• UDI-Public: 00815948020900
• Combination Product (y/n): Y
• PMA/PMN Number: K190464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Catalogue Number: PSR3D
• Device Lot Number: F90675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 87 YR