MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problems Break (1069); Filling Problem (1233); Material Puncture/Hole (1504); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Nausea (1970); No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.As the device was not returned, an analysis investigation could not be performed.Additionally, the lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that patient had a realize lap band placed 2009.Had always had problems with fills/unfills d/t "flipped port".Had bouts of nausea and pain which were reported to md.Decided to have lap band removed and get sleeve gastrectomy; had pre-op ego done on which showed a "sore spot'' on the stomach; md gave prilosec to take until 1 month after gastrectomy.Md "did" diagnose band erosion, nor did he remove the 5 ml fluid present in the band.Three weeks prior to surgery the fluid was removed from the band.The unfill procedure was the most painful difficult one in the 9 years of them.The sink at the port site became very red, painful and warm to touch.With much time spent on warm compresses and neosporin ointment it subsided.Went in to surgery (b)(6) 2018 with surgeon coming out after stating how bad the erosion and scar damage and said the entire band was in the stomach.There was a large hole and md had to make a second hole to reach areas to be repaired.He stated that some people are able to wait 6 to 9 months and try a gastrectomy again after scar tissue has healed better but he voiced some doubt that this would be possible due to the severity of the damage.Patient had 5 incisions with a drain present for nearly 2 weeks with large amounts of blood drainage.The largest incision was where the port had been.It was very deep and had copious amounts of yellow green drainage with 6 times a day dressing changes.Patient ended up on an antibiotic for an infection at the port site.The surgeon stated the open stomach drained its bacteria up the tubing to this area which is why the infection was severe.Patient returned to the md 9 days later and he sliced open the small fragile layer of skin on the site to allow the large amounts of drainage to flow out.Applied neosporin and wet to dry dressing 3 to sometimes 8 times a day for 2 weeks.Six weeks after surgery patient still had a 1/2 cm x 1/3 cm open hole approximately 1/2 inch deep, drainage is thin bloody in moderate amounts.The entire abdominal area is quite sore with sometimes sharp stabbing pains and burning sensations.Patient has bouts of nausea as when the lap band in.

• 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: 8180164
• MDR Text Key: 130898596
• Report Number: 3005075853-2018-15269
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2018

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: SAGBX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention