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

Model Number PSR3D-A

Device Problem Break (1069)

Patient Problems Edema (1820); Paresis (1998); Vascular Dissection (3160)

Event Date 12/03/2017

Event Type  Death  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Dissection/perforation is a known and anticipated complication with these types of procedures and are noted in the device labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure in the right distal internal carotid artery (ica) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician advanced the psr3d through a penumbra system 3max reperfusion catheter (3maxc) to the target location and advanced the psr3d out of the 3maxc.While attempting to retract the psr3d back into the 3maxc, the physician twisted the pusher wire of the psr3d as it was retracted, and the psr3d broke off and remained in the patient.The physician attempted to re-sheathe the psr3d by advancing the ace68 over it, and then attempted to use a snare device to retrieve it.However, attempts to retrieve the psr3d were unsuccessful causing intimal dissection of the right ica; therefore, the procedure was aborted.The patient remained hemiplegic on the left side, however was able to talk and move right extremities.It was reported that the patient¿s anatomy was moderately tortuous, and that the physician had thought the thrombus looked calcified when examined in the ct image, however while engaging the thrombus the physician reported it was softer than expected.The physician was unable to determine the extent of cerebral injury related to the device separation.The patient developed cerebral edema requiring a right sided hemicraniotomy for decompression.During hospital course, the patient also developed lower extremity deep vein thrombosis and respiratory failure.After discussions with the patient's family, care was transitioned to comfort measures and death occurred on (b)(6) 2017.

Manufacturer Narrative

Although initially reported as not returning, the device was returned for investigation; therefore, the report was updated accordingly.Outcomes attributed to adverse event: death.Pma: 162901.Results: the returned item appeared to be a coiled wire with significant thrombus attached.The filament diameter and coil diameter were measured with a calibrated snap gauge to be 0.0022¿ and 0.0132¿ respectively.Conclusions: evaluation of the returned item revealed a coiled wire with thrombus attached.Upon removing the attached thrombus, the wire was found to be broken in several locations.This damage was likely a result of the removal process during autopsy or other manipulations outside the patient body.The measurements taken of the wire indicate a possibility that the returned item may be part of a broken psr3d delivery wire.However, due to the lack of device returned and its condition, the identity and failure mode of the returned item is unknown.Penumbra system 3d revascularization devices are inspected during in-process inspection and during quality inspection after manufacturing.The device record was verified and confirmed all accepted units met specification.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Manufacturer Narrative

Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.

• 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: 7158706
• MDR Text Key: 96209889
• Report Number: 3005168196-2018-00001
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548017853
• UDI-Public: 00814548017853
• Combination Product (y/n): Y
• PMA/PMN Number: K162901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,12/03/2017

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/16/2020
• Device Model Number: PSR3D-A
• Device Catalogue Number: PSR3D
• Device Lot Number: F78206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• 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: 12/03/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 02/28/2018; 01/14/2005
• Supplement Dates FDA Received: 05/03/2018; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 120