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

Catalog Number	400SMTXSFT0206
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/11/2019
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.Potential adverse events in the labeling with the penumbra smart coil system include, but are not limited to, hematoma or hemorrhage at the site, aneurysm rupture, including death.Therefore, it was determined that the reported adverse event was an anticipated complications.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra smart coils (smart coils) and a non-penumbra microcatheter.During the procedure, the physician successfully placed six coils in the aneurysm using the microcatheter.While placing the next smart coil, the physician felt the smart coil was stiff but was able to place the rest of it.Subsequently, the aneurysm ruptured.The physician continued the procedure.Due to a loop of the smart coil being displaced in the anterior cerebral artery (aca), a stent was placed.It was reported that the patient had minimal intracranial bleeding that stopped within seconds.The procedure was completed using additional smart coils.The outcome was a complete aneurysm coiling with minimal residual filling.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report:3005168196-2019-02449.1.Section h.Box 5.Labeled for single use?.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9555515
• Report Number: 3005168196-2019-02449
• Device Sequence Number: 14181547
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019
• 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: 04/29/2024
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F90016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/07/2020
• 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: 44 YR
• Date Report Sent to FDA: 01/01/2005