MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ACTICON NEOSPHINCTER; IMPLANTED FECAL INCONTINENCE DEVICE

Catalog Number 72401962

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Nausea (1970); Sepsis (2067); Vomiting (2144); Obstruction/Occlusion (2422); Abdominal Distention (2601); Constipation (3274)

Event Type  Injury  

Manufacturer Narrative

Date of event: 2017.Catalog # (b)(4), serial# (b)(4), expiration date (b)(6) 2008, (b)(6) 2003 ; catalog # (b)(4), serial# (b)(4), expiration date (b)(6) 2008, (b)(6) 2003.

Event Description

It was reported the patient had her artificial bowel sphincter removed due to a small bowel obstruction.The patient also indicated that she had "changes in bowel habits" after the implant surgery and eventually again in 2017.The three piece device was removed in three different surgeries in 2017, the cuff, then pump, then reservoir.After the third removal surgery, the patient stated she became septic.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Explant dates: catalog # 72401962, serial#(b)(4), cuff explant date (b)(6) 2017.Catalog # 72402287, serial#(b)(4), pump explant date (b)(6) 2017.Concomitant medical products: catalog # 72402106, serial# (b)(4), expiration date (b)(6) 2008.Device manufacture date: 04/03/2003.Reported in mfr report #2183959-2018-xxxxxx.

Event Description

Same patient/device as: 2183959-2018-00049.Additional information received indicated that the patient was admitted to the emergency department (ed) on (b)(6) 2017 with symptoms of bowel obstruction of severe abdominal pain, flank pain, and emesis.The pain was described as colicky and cramping periumbilical pain without radiation.The patient continued to report anorexia, belching, constipation, nausea, and vomiting and was noted to be "mildly distended." a ct scan indicated the bowel obstruction appeared to be "adhesive." the patient was treated with nonoperative therapy and discharged.The patient was seen by her physician on (b)(6) 2017 for a follow up on her acticon artificial bowel sphincter (abs) device and "dysfunction.The physician noted that she was previously seen in 2014 at which point it was noted that the "cuff around the rectum was very loose." "the function is even worse now." it appears that no treatment was performed for the loose cuff in 1014.The patient was seen for a follow up appointment by her physician on (b)(6) 2017 as was concerned that she may have an erosion as "her primary care doctor examined her and felt that she could detect an erosion also." the patient had the abs cuff component removed on (b)(6) 2017 as the cuff had eroded through the posterior midline of the vagina.The pump component was removed on (b)(6) 2017 also due to "eroded artificial bowel sphincter." further complications were reported following the explant of the cuff and pump components.

• Brand Name: AMS ACTICON NEOSPHINCTER
• Type of Device: IMPLANTED FECAL INCONTINENCE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7387917
• MDR Text Key: 104027195
• Report Number: 2183959-2018-00037
• Device Sequence Number: 1
• Product Code: MIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/12/2008
• Device Catalogue Number: 72401962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2003
• 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; Required Intervention
• Patient Weight: 90