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

Catalog Number	400SMTSFT0304
Medical Device Problem Codes	Entrapment of Device (1212); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/07/2016
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The patient was undergoing a re-treatment coil embolization procedure in the middle cerebral artery (mca) using penumbra smart coils (smart coils).During the procedure, the physician deployed an initial smart coil into the aneurysm but did not like how the loop of the coil fell at the neck of the aneurysm so he readjusted the position of the coil and was still unsatisfied with the placement.Therefore, the physician decided to resheath the smart coil and continue the procedure using a new smart coil.The physician successfully deployed and detached this new smart coil into the aneurysm.However, while removing the microcatheter, the smart coil pulled out of the aneurysm.The physician attempted to push the coil mass back into the aneurysm but was unsuccessful and subsequently, the coil became lodged in the distal mca.The physician then attempted to retrieve the smart coil using snare devices but could not get the guidewire and microcatheter to the coil mass.The physician continued the procedure by implanting three coils from another manufacturer into the aneurysm.After hours of unsuccessful attempts to retrieve the smart coil mass, the physician aborted the procedure.It is unknown if there was an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5551854
• Report Number: 3005168196-2016-00433
• Device Sequence Number: 10878435
• Product Code: HCG
• UDI-Device Identifier: 00814548015033
• UDI-Public: 00814548015033
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2016

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: Physician
• Device Expiration Date: 08/05/2020
• Device Catalogue Number: 400SMTSFT0304
• Device Lot Number: F65208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2016
• Initial Report FDA Received Date: 04/06/2016
• 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: 46 YR