MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR; DXE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Perforation of Vessels (2135)

Event Date 04/11/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the indigo aspiration system instructions for use (ifu) include, but are not limited to, hematoma or hemorrhage at access site, vessel spasm, thrombosis, dissection, or perforation, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

Event Description

During its post-market surveillance activities on (b)(6) 2022 penumbra inc.Became aware of a journal article titled, "recurrent pulmonary embolism in a patient after covid-19 treated with percutaneous and surgical approach" (kosiorek et al.2021).The event date was not provided; however, the article was received on 11-apr-2021 and documents a single case of catheter-directed therapy (cdt) to treat pulmonary artery (pa) embolism using an indigo system separator, an indigo system aspiration catheter, and a penumbra engine (engine).During the procedure, several passes were made with the indigo system separator and the indigo system aspiration catheter resulting in partial thrombus removal.However, the subsegmental branch of the left pa was perforated by a wire resulting in hemoptysis.The patient was administered protamine sulfate and no bleeding site was detected via angiography.After the procedure, low-molecular-weight heparin (lmwh) was initially reduced but was reintroduced at a full therapeutic dose over the next twenty-four hours.Four days later, the patient developed symptoms of cardiogenic shock with tachycardia, hypotension, and hypoxemia with a need for inotropic and vasopressor support and echocardiographic signs of pulmonary embolism recurrence.Surgical embolectomy was elected by the pulmonary embolism response team (pert) and the periprocedural course was uncomplicated.The six-month follow-up was free of venous thromboembolism events (vte).The identity of the wire which perforated the left pa was not specified within the published literature source.Therefore, the relationship between the perforation and the indigo system separator is unknown.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 events within this literature source.

• Brand Name: INDIGO SYSTEM SEPARATOR
• Type of Device: DXE
• 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: 14366904
• MDR Text Key: 291493146
• Report Number: 3005168196-2022-00209
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,05/11/2022

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?: No
• 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
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/12/2022
• 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: 48 YR
• Patient Sex: Male