FDA.reportPublic FDA data

MAUDE MDR 4918025

MDR report key
4918025
Report number
3006722112-2015-00206
Event key
0
Event type
3
Date of event
2015-06-04
Date received
2015-07-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. LAURA LEBOEUF
Address
1120 S CAPITAL OF TEXAS HWY BULDING 1, SUITE 300 AUSTIN TX 78748 US
Phone
855-855-8555
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)IMPLANT, INTRAGASTRIC FOR MORBID OBESITYALLERGANLTINAB-22401833747Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-1301. R

Event Narratives#

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED "LAP-BAND LAPAROSCOPIC REMOVAL, PERSISTENT NAUSEA AND VOMITING IN SPITE OF REPLACEMENT IN ANATOMICAL POSITION". DIAGNOSTIC TESTING SHOWED "PROXIMAL GASTRIC OBSTRUCTION IATROGENIC FROM THE LAP-BAND. THE PATIENT MAY HAVE HAD A PREVIOUS HIATAL HERNIA". ALSO REPORTED, "GASTRIC EROSION WITH A SUPERFICIAL ULCER PROXIMAL, LIKELY FROM TIGHT LAP-BAND. THIS ALSO INVOLVES THE NECK". "ESOPHAGUS, LIKELY FROM CHRONIC IRRITATION. MILD GASTRITIS". PREVIOUS DIAGNOSTIC TESTING SHOWED "DISPLACED LAP-BAND OR ESOPHAGUS". A REVISION SURGERY WAS PERFORMED FOR A SLIPPED LAP-BAND AND THEN EVENTUALLY EXPLANTED.

N

Patient 1

(B)(4). TAPER II. THE REPORTER OF THE COMPLAINT WAS ASKED TO RETURN THE PRODUCT FOR ANALYSIS. THE DEVICE HAS NOT YET BEEN RECEIVED BY ALLERGAN. BASED UPON THE SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. ALLERGAN HAS NOT RECEIVED THE PRODUCT AT THIS TIME. THEREFORE NO ANALYSIS OR TESTING HAS BEEN DONE. BAND SLIPPAGE, OBSTRUCTION, GASTRIC EROSION, ULCER, IRRITATION, HERNIA, VOMITING AND NAUSEA ARE SURGICAL/PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE EVENT DATE, PATIENT DATA OR FURTHER EVENT DETAILS.

N

Patient 1

TAPER II. VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ANALYSIS NOTED THE ACCESS PORT TUBING WAS BROKEN WITH STRIATIONS DESCRIBED AS SURGICAL DAMAGE. ANALYSIS NOTED THE BAND TUBING WAS BROKEN WITH STRIATIONS CONSISTENT WITH SURGICAL END CUT TO REMOVE THE DEVICE.

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTED "LAP-BAND TM LAPAROSCOPIC REMOVAL, PERSISTENT NAUSEA AND VOMITING IN SPITE OF REPLACEMENT IN ANATOMICAL POSITION". DIAGNOSTIC TESTING SHOWED "PROXIMAL GASTRIC OBSTRUCTION IATROGENIC FROM THE LAP-BAND TM. THE PATIENT MAY HAVE HAD A PREVIOUS HIATAL HERNIA". ALSO REPORTED, "GASTRIC EROSION WITH A SUPERFICIAL ULCER PROXIMAL, LIKELY FROM TIGHT LAP-BAND TM. THIS ALSO INVOLVES THE NECK." "ESOPHAGITIS, LIKELY FROM CHRONIC IRRITATION. MILD GASTRITIS". PREVIOUS DIAGNOSTIC TESTING SHOWED "DISPLACED LAP-BAND TM OR ESOPHAGUS". A REVISION SURGERY WAS PERFORMED FOR A SLIPPED LAP-BANDND THEN EVENTUALLY EXPLANTED.