MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REALIZE ADJ GASTRIC BAND STR; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB22

Device Problems Expulsion (2933); Migration (4003)

Patient Problems Abdominal Pain (1685); Rheumatoid Arthritis (1724); Erosion (1750); Fatigue (1849); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Investigation summary: this is an evaluation of six pictures sent by the account.Images 1, 2, 3, 5: are images of tissue with what appears to have an erosion.Image 4 is the package of a realize band.Image 6 is the gastric band in a plastic case.While it was not possible to draw a definitive conclusion regarding the root cause of the reported event and evaluation of the device cannot confirm events that are physiological in nature, it was observed within the instruction for use (ifu) that infection and erosion are recognized adverse events associated with gastric banding and the realize band.Events of this type continue to be trended and monitored.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.

Event Description

It was reported that the patient had a laparoscopic gastric band procedure on (b)(6) 2008, where a realize band was implanted.In 2017, the patient started experiencing fatigue and gastritis.The patient went to her doctor, had tests performed, was diagnosed with rheumatoid arthritis, had elevated liver functions and elevated white blood counts.The patient was also tested by a gastrointestinal doctor, liver doctor and hematologist, thinking she had a blood disorder.On (b)(6) 2019, the patient went to the hospital with acute abdominal pain and was diagnosed with acute pancreatitis.A cat scan was performed the found the realize band had completely eroded through the stomach and had migrated into the colon, leaving a hole in the stomach.The doctor operated on the patient, cut and removed the port line and removed the port, itself.The patient had to poop out the remainder of the band.All parts of the band were sent to pathology.The patient was in the hospital for six days and has fully recovered.All tests are normal.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8613200
• MDR Text Key: 145161754
• Report Number: 3005075853-2019-19082
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

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
• Device Catalogue Number: RLZB22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention