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

Model Number 400SMTSTD0615

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

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.This report is associated with mfr report numbers: 3005168196-2017-00352, 3005168196-2017-00353.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure to treat a basilar tip aneurysm using penumbra smart coils (smart coil).During the procedure, after the third smart coil was deployed and detached, the angiography showed a protrusion of a previously placed coil.The physician continued the procedure by placing six additional smart coils.Towards the end of the procedure, clot formation was identified on the displaced loop of coil and an integrilin drip was started.The physician then decided to place a stent in order to tack the protruding coil against the wall of the vessel.The patient was discharged home on (b)(6) 2017.The reported clot formation was adjudicated to have no relationship to the penumbra devices.However, the reported coil protrusion was possibly related to the aneurysm, procedure and penumbra smart coils.It is unknown which of the three previously placed smart coils protruded out.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2017-00351.1.Section d.Box 10.Returned to manufacturer (remove date) this report is associated with mfr report numbers: 1.3005168196-2017-00352; 2.3005168196-2017-00353.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6401544
• MDR Text Key: 69839893
• Report Number: 3005168196-2017-00351
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014661
• UDI-Public: 00814548014661
• 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
• Report Date: 01/01/2005,02/12/2017

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 Model Number: 400SMTSTD0615
• Device Catalogue Number: 400SMTSTD0615
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/31/2017
• 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: 02/12/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: 01/14/2005
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR