MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) ORBERA INTRAGASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number B-50000

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Vomiting (2144); Constipation (3274)

Event Date 08/16/2015

Event Type  malfunction  

Manufacturer Narrative

No additional information has been reported to allergan regarding the model number, serial number, the event date, implant date, explant date, diagnostic testing, patient data or further event details.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Device labeling addresses the reported event of pain as follows: possible complications of the use of the orbera¿ system include: abdominal or back pain, either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.Device labeling addresses the reported event of vomit as follows: possible complications of the use of the orbera¿ system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.Continuing nausea and vomiting.This could results from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.Balloon replacement: caution: a larger initial fill volume in the replacement balloon may result in severe nausea, vomiting or ulcer formation.

Event Description

Healthcare professional reported patient had intensive pain and uncontrollable vomiting.A scan showed presence of gastric balloon which caused gastric distension and occlusive syndrome.

Manufacturer Narrative

Device labeling addresses the reported event of bowel complication as follows: indications for use: caution: the risk of balloon deflation and intestinal obstruction(and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months.This has already been experienced.Warnings and precautions: the risk of balloon deflation and intestinal obstruction(and therefore possible death related to intestinal obstruction) is significantly higher when balloons are left in place longer than 6 months or used at larger volumes(greater than 700cc).Bowel obstructions have been reported due to deflated balloons passing into the intestines and have required surgical removal.Some obstructions have reportedly been associated with patients who have diabetes or who have had prior abdominal surgery, so this should be considered when assessing the risk of the procedure.Bowel obstructions can result in death.The risk of intestinal obstruction may be higher in patients who have had prior abdominal or gynecological surgery.The risk of intestinal obstruction may be higher in patients who have a dysmotility disorder or diabetes.Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications.Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.

Event Description

Healthcare professional reported patient had intensive pain and uncontrollable vomiting.A scan showed presence of gastric balloon which caused gastric distension and occlusive syndrome.

Manufacturer Narrative

Supplement #2 - medwatch sent to fda on 02/25/2016.Device evaluation summary: the device was returned for analysis, and visual inspection noted the device was discolored, and appeared to be yellow and brown in color.A darker discoloration was observed on the edge of the device.Brown, red and white particles were noted on the outer surface of the device.Device analysis observed five openings on the shell, consistent with surgical damage from a removal tool.A valve test was performed and no obstruction was noted.A fill tube test was performed, and no blockage was observed.

Manufacturer Narrative

Supplement #3 - medwatch sent to the fda on 27-jul-2017.Device evaluation summary: additional testing was performed on the device.Foreign matter was noted in the valve chamber.The slit valve was removed from the device using a razor blade for testing.Pressure testing of the slit valve was performed, the outside to inside pressure was noted to be 1.27 psi.The inside to outside pressure was noted to be 10 psi.The valve was cross-sectioned along the sealing mechanism, and examined microscopically with a magnification between 20x-60x.The surface of sealing mechanism showed typical axial lines parallel to the valve access due to the blade cutting direction during valve manufacturing.The inner edge of the cut appeared to be more defined than the opposite edge, a likely consequence of the valve slitting process.

• Brand Name: ORBERA INTRAGASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer (Section G): ALLERGAN; global park free zone; 900 global park; la aurora de heredia, ; CS
• Manufacturer Contact: laura leboeuf ; 1120 s. captial of texas hwy; bldg 1, ste. 300; austin, TX 78746 ; 5122795141
• MDR Report Key: 5075139
• MDR Text Key: 25697925
• Report Number: 3006722112-2015-00363
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2017

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: B-50000
• Device Lot Number: 2679452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2015
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided; 03/01/2017
• Supplement Dates FDA Received: 02/25/2016; 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization
• Patient Age: 47 YR