MAUDE Adverse Event Report: ALLERGAN / APOLLO ENDOSURGERY COSTA RICA S.R.L. GASTRIC ADJUSTABLE LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Achalasia (1692); Anemia (1706); Dysphagia/ Odynophagia (1815); Fatigue (1849); Vomiting (2144); Test Result (2695); Constipation (3274); Wheezing (4463)

Event Date 03/01/2019

Event Type  Injury  

Event Description

Had gastric lap band placed in 2013.Developed severe gerd/reflux starting in 2018.Issues persisted and got worse.Developed achalasia and my esophagus became severely dilated.I would wake up at night choking to the point i would vomit.I could only tolerate approximately 5 solid foods otherwise my diet was purely liquid.Starting in mid 2019 i stopped even being able to digest and swallow the 5 solid foods i was once able to tolerate.I went to numerous specialist, attempted to have an endoscopy done several times but the doctor was not able to advance scope down my throat due to the torturous condition of my esophagus and the severe achalasia and dilation.I went and saw a thoracic surgeon, threegastro doctors and 3 bariatric physicians.My insurance refused to cover the removal of the band.I developed aspiration pneumonia twice and even after remove i continue to not be able to lie down flat in bed.I was wheezing constantly.I developed severe anemia, all my numbers for my vitamin d, b-12 and hemoglobin were in single digits for the last year.I still suffer from fatigue.I was told by doctor i may end up on feeding tube rest of my life if the band didn't come out.The band caused severe complications with constipation.The last two months before i had the band removed there were days that i ate nothing because even liquids wouldn't go down.I vomited every day of my life for the last two years before my band was removed.I suffered from malnutrition due to the band.Fda safety report id# (b)(4).

• Brand Name: GASTRIC ADJUSTABLE LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN / APOLLO ENDOSURGERY COSTA RICA S.R.L.
• MDR Report Key: 10605993
• MDR Text Key: 209454681
• Report Number: MW5096958
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/27/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 152