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

Catalog Number	PSR3D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 of the middle cerebral artery (mca) using a penumbra system 3d revascularization device (psr3d).During the procedure, the physician attempted to make a pass using the psr3d with a non-penumbra microcatheter, however, the stent broke off from the pusher assembly and remained in the m2.It was reported that the stent did not hold its shape and appeared that some of the tines ¿were outside of the m2¿.Therefore, the physician implanted a non-penumbra stent to stabilize the psr3d against the vessel wall and re-profuse the vessel.The next day, the patient¿s condition was stable, and the mri showed a small stroke with a relatively intact penumbra.The vessel had a tici 2b flow.
Additional Manufacturer Narrative
Results: the psr3d was fractured on the delivery wire approximately 198.5 cm from the proximal end, distal to the attachment tip.The psr3d was fractured and, therefore, the psr3d could not be functionally tested.During functional testing, a 0.025¿ stainless steel mandrel was unable to be advanced through the returned non-penumbra microcatheter.A demonstration psr3d was able to be advanced through the returned non-penumbra microcatheter.Conclusions: evaluation of the returned psr3d revealed that the stent was fractured off the delivery wire.If the device is retracted forcefully such that the tensile specification is exceeded, the device may become fractured off the delivery wire.The use of a reperfusion catheter was not identified in the reported complaint.This may have contributed to the difficulty experienced during the procedure.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2019-01021 1.Section h.Box 6.Results code 1.

• Brand Name: PENUMBRA SYSTEM 3D REVASCULARIZATION DEVICE
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8640588
• Report Number: 3005168196-2019-01021
• Device Sequence Number: 1858054
• Product Code: NRY
• UDI-Device Identifier: 00814548017839
• UDI-Public: 00814548017839
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2019
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Catalogue Number: PSR3D
• Device Lot Number: F85217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 01/14/2005
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/28/2019; 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005