MAUDE Adverse Event Report: ETHICON INC. INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER; BARRIER, ABSORBABLE, ADHESION

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fever (1858); Unspecified Infection (1930); Pain (1994); Perforation (2001); No Code Available (3191)

Event Date 07/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/06/2015.(b)(4).Conclusion: the device information for use warns ¿the safety and effectiveness of interceed barrier in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established.¿ to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by the patient that she underwent a laparoscopic hysterectomy using the davinci on (b)(6) 2015 and an absorbable adhesion barrier was used.The patient stated she developed abdominal pain 4 to 6 weeks later.The patient was hospitalized for antibiotic therapy to treat an infection.The patient had a ct scan of the abdomen at that time which "found a hole in her abdomen." the patient had 2 more hospitalizations for vaginal cuff repair on (b)(6) 2015.The patient reported the absorbable adhesion barrier was found in place during one of the surgeries and stated "it stayed inside and did not dissolve." currently, the patient is experiencing minor cramping and pain.Additional information has been requested.

Manufacturer Narrative

Date sent to fda: 03/20/2017.It was reported by the patient that on (b)(6) 2015, she underwent a partial hysterectomy due to ovarian cysts and the absorbable adhesion barrier was implanted.After the partial hysterectomy, the patient experienced moderate abdominal pain for several months.On (b)(6) 2015, the pain became unbearable and the patient went to the emergency room and was admitted and discharged on (b)(6) 2015 with c diff.On (b)(6) 2015, the patient went to the emergency room with a fever and severe abdominal pain.The next day, the patient had surgery and the doctor opined that a piece of the adhesion barrier did not dissolve and caused a perforation which was causing the complications.The patient was discharged on (b)(6) 2015.On (b)(6) 2015, she went to a urgent care clinic and was transferred to a hospital with a blood clot in the right lung due to the recent surgery.The patient was discharged on (b)(6) 2015.She was admitted again on (b)(6) 2015 due to low blood pressure and was in icu.The patient was discharged on (b)(6) 2015.On (b)(6) 2015, she went to the hospital due to a prolapse.The patient went into emergency surgery and was discharged on (b)(6) 2015.The patient has experienced major depression and started tms on (b)(6) 2015.On (b)(6) 2016, the patient went to the hospital, was admitted and had surgery on (b)(6) 2016.She was discharged on (b)(6) 2016.Since then, the patient reports that she can no longer enjoy sex without some kind of pain and was unable to work.(b)(4).

Manufacturer Narrative

Date sent to fda: 05/24/2017.Additional information was requested and the following was received: the patient advised that the implant has now been removed.No additional information was provided.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the patient underwent robotic total laparoscopic hysterectomy, left salpingo-oopherectomy, right salpingectomy with preservation of the right ovary and a cystoscopy.Operative note states vaginal vault was closed with covidien v-loc 180 suture ¿with the first two stitches incorporating right uterosacral ligament and being locked with the suture being run continuously across the vaginal vault to the left uterosacral ligament, which was incorporating the angle and the suture was locked.¿ three pieces of interceed were placed ¿in the vaginal vault, left pelvic sidewall and the right ovary.¿ approximately 4 months postop, patient was reoperated for laparoscopic lysis of adhesions, drainage of pelvic abscess and closure of a central vaginal perforation.The operative notes state a 1 cm perforation at the apex of the vagina with extrusion of interceed was identified and the interceed was removed.The perforation was closed with interrupted 0 vicryl suture.No small bowel adhesions were noted and no dehiscence was observed.A general surgeon then performed the lysis of adhesions at the top of the vaginal cuff where no evidence of fistula tract was identified; however moderate adhesions were noted.The surgeon was then able to visualize the pelvis where an abscess was identified and aspirated out.He then identified the vaginal cuff, confirmed closure and placed the omentum down in the area to cover the vaginal cuff and allow the small bowel to fall back on top.

• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5129776
• MDR Text Key: 27548123
• Report Number: 2210968-2015-14466
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Followup,Followup,Followup
• Report Date: 09/15/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/20/2017; 05/24/2017; 06/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 34 YR
• Patient Weight: 59