MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number 400SMTXSFT2H06

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Unintended Movement (3026)

Patient Problems Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

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.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The device is implanted in the patient.

Event Description

The patient underwent a coil embolization procedure in the right anterior communicating artery (acom) using penumbra smart coils (smart coils).It was reported that small amount of coil herniation was noted through the aneurysm's dome suggesting that there was an intracranial perforation of the aneurysm.However there are no clinical signs of perforation and the control angiography demonstrated no extravasation of contrast.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that additional information was provided on 27-mar-2018 and therefore, the following sections are being updated: the manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient underwent a coil embolization procedure in the right anterior communicating artery (acom) using penumbra smart coils (smart coils).It was reported that small amount of coil herniation was noted through the aneurysm''s dome suggesting that there was an intracranial perforation of the aneurysm.However there are no clinical signs of perforation and the control angiography demonstrated no extravasation of contrast.The vessel perforation was reported to be an adverse event related to the smart coil.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report 3005168196-2017-01275: 1.Section b.Box 1.Adverse event and/or product problem.2.Section b.Box 5.Describe event or problem.3.Section h.Box 6.Patient code 1 updated from 2199 to 2135.4.Section h.Box 6.Conclusion code 1 updated from 67 to 22.5.Section h.Box 6.Conclusion code 2 updated from 95 to 4315.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 smart coil system include, but are not limited to dissection, or perforation, coil herniation into parent vessel, thrombosis, distal embolization, emboli, embolic stroke and other cerebral ischemic events, vessel spasm, including death.Therefore, it was determined that the reported adverse event was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6732435
• MDR Text Key: 80804142
• Report Number: 3005168196-2017-01275
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• 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: 01/01/2005,07/01/2017

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: 11/21/2021
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F72191
• Was Device Available for Evaluation?: No
• 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: 07/01/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 03/27/2018; 01/14/2005
• Supplement Dates FDA Received: 03/28/2018; 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR