MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062910

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

Patient Problems Aspiration/Inhalation (1725); Death (1802); Pneumonia (2011)

Event Date 03/23/2020

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the standard us list number.The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event was not returned and remained implanted in the patient; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2020, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.During the endoscopic procedure the patient went into atrial fibrillation, experienced aspiration immediately after the procedure, and discharged home the same day.On (b)(6) 2020, the patient was admitted to the hospital for atrial fibrillation treated with unknown medications, and pneumonia treated with unknown intravenous antibiotic medication.The patient left the hospital on (b)(6) 2020 against medical advice.The patient was re-hospitalized for the reported adverse events from (b)(6) 2020 to (b)(6) 2020; and then transferred to a rehab facility, where he currently remains.

Manufacturer Narrative

Reference record: (b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the patient passed away on (b)(6) 2020.The causes of death were reported as cardiac arrest and pneumonia.Abbvie has chosen to report this complaint conservatively.It is unknown if the event of pneumonia is the same event that was previously reported or a new event not related to on (b)(6) 2020 procedure.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 9960290
• MDR Text Key: 187864620
• Report Number: 3010757606-2020-00262
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR