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

Device Problem Migration (4003)

Patient Problems Hemoptysis (1887); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)

Event Date 01/29/2021

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.Potential adverse events in the labeling with the ruby coil system include, but are not limited to, vessel spasm, device malfunction, thrombosis, thromboembolic episodes, inadequate embolization, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2022-00060.

Event Description

During its post-market surveillance activities on (b)(6) 2022, penumbra inc.Became aware of a journal article titled, "nonfibered packing coil embolization of pulmonary artery pseudoaneurysm resulting in a delayed endobronchial coil migration" (schwertner et al.2021).This article highlights a single case of endobronchial coil pack migration one month after an iatrogenic pulmonary artery pseudoaneurysm embolization procedure using ruby coils (30cm and 60cm).It was reported that the coil configuration was unchanged after a follow-up computed tomography scan (ct) three weeks post-procedure.However, one month after the coil embolization procedure, the patient expectorated a three centimeter firm blood clot accompanied by a tickling sensation in the throat and massive hemoptysis.Further ct scans demonstrated coil pack migration into the left mainstem bronchus and trachea.Next, a stent graft was implanted to entrap the coils and an additional coil embolization procedure was performed with non-penumbra coils.However, within hours of the procedure, a ct scan demonstrated coil migration into an adjacent pneumatocele.Therefore, left pneumonectomy was performed with a resolution of the hemoptysis on nine months of clinical follow-up.It was not possible to ascertain specific device information from the article, nor to match the events reported with previously reported complaints.Therefore, this report addresses all malfunctions and/or adverse events within this literature source.

Manufacturer Narrative

This report is associated with mfr report number: 1.3005168196-2022-00060.

• Brand Name: RUBY 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: 13551970
• MDR Text Key: 286584019
• Report Number: 3005168196-2022-00059
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR
• Patient Sex: Male