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

Catalog Number 400SMTXSFT1H03

Device Problems Material Protrusion/Extrusion (2979); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2017

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 manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the right anterior choroidal artery using penumbra smart coils (smart coils).During the procedure, the physician placed a non-penumbra microcatheter within the aneurysm, inflated a non-penumbra balloon catheter over the neck of the aneurysm and then attempted to deploy a smart coil into the aneurysm.As the smart coil was deployed in the aneurysm, a portion of it extruded from the aneurysm dome into the subarachnoid space.The physician left the smart coil in the patient and administered ten milligrams of protamine to reverse the heparin.The balloon was deflated and an angiography run was performed.It was noted that an extremely small amount of extravasation was seen upon repeat angiography, but a few seconds later, it was no longer seen.The smart coil was detached and no more coils were deployed.The procedure was completed with the coils used and the patient had a raymond-roy occlusion class score of 3.It is unknown if the small amount of extravasation was related to the penumbra device.On a later date, due to the coil protrusion, the aneurysm was treated using a pipeline stent.The patient is currently neurologically stable and was discharged home on (b)(6) 2017 with a national institutes of health stroke scale (nihss) score of 0.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• 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: 6734159
• MDR Text Key: 80749604
• Report Number: 3005168196-2017-01224
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015231
• UDI-Public: 00814548015231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2017

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: 01/31/2021
• Device Catalogue Number: 400SMTXSFT1H03
• Device Lot Number: F67687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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): Required Intervention
• Patient Age: 34 YR