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Catalog Number UNKAA077
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Hernia (2240); Disability (2371); Obstruction/Occlusion (2422)
Event Date 03/13/2019
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, adhesions and subsequent surgical intervention to remove the hernia mesh. The instructions-for-use supplied with the device lists recurrence and adhesions as possible complications. This emdr submitted to represent the bard/davol ventralex mesh (device #2). Additional emdrs were submitted to represent the bard/davol ventralex st mesh (device #1) and bard/davol phasix st (device #3). Should additional information be provided, a supplemental emdr will be submitted.
Event Description
Attorney alleges adverse patient outcomes against bard/davol ventralex st mesh, ventralex mesh and phasix st mesh: (b)(6) 2015 ¿ the patient underwent an incisional hernia repair and an incisional herniorrhaphy for abdominal hernia. The surgeon had implanted a bard/davol ventralex st mesh to repair the hernia. (b)(6) 2015 - the patient presented to the surgeon for a post-operative follow-up. The surgeon observed drainage from the patient's wound and noted that the patient was complaining of "abdominal pain with position changes". The surgeon suggested physical limitations as the patient healed, and to return with any problems. (b)(6) 2015 - during another follow-up, the surgeon noted that the incision was producing less drainage, but the patient was still experiencing pain during position changes. (b)(6) 2020 - the patient presented for an ultrasound to confirm the cause and extent of fluid accumulation causing the surgeon to express concern for an abscess relating to the ventralex st hernia surgery. (b)(6) 2015 - the patient was complaining of a "new onset epigastric and left abdominal pain". The patient subsequently underwent a ct scan of abdomen, in which the surgeon observed that the fluid accumulation "in the right abdominal soft tissues had resolved, with only induration and overlying skin thickening remaining. The findings are likely due to residual cellulitis and nearly resolved intra-abdominal air fluid collection beneath the right abdominal rectus musculature. Only a trace amount of fluid in the right lower quadrant remains" and the surgeon diagnosed the patient with an abscess. (b)(6) 2015 ¿ the patient had complaints of abdominal pain with position changes and increase in gas and bowel movements. The surgeon observed serous fluid in the drain bulb on this visit and noted superficial surgical site infection subsequent to having had the previous drain placed. (b)(6) 2015 - cultures from the drain showed enterococcus and staphylococcus and the surgeon also noted that the postop wound infection was resolving. (b)(6) 2015 - the patient had severe pain and went to the er, underwent a ct scan which ¿showed thickened and dilated small bowel near the lateral edge of the mesh¿. The patient explained that a "bulge just superior to the scar near the lateral edge" was present when the patient went to the er, "but that [it had] resolved spontaneously. " upon review of the ct scan, the surgeon noted ¿inflammatory changes surrounding bowel and muscle at lateral edge of mesh¿, prescribed more narcotics for pain relief and recommended a ¿laparoscopic loa and possible mesh replacement¿. (b)(6) 2015 ¿ the patient returned for complaints pertaining to incision and abdominal pain. The surgeon concluded that the patient ¿indeed had a recurrent incisional hernia lateral probably to the mesh, at the site of abscess¿, while also noting that the patient did not have an "active infection" and recommended ¿a repeat ct scan in 4 weeks to see if the piece of small bowel is still close to operating room in the recurrent hernia. If so, at some point he will have to have this repaired. If not, i would recommend he not do anything and wait at least a year from the time of his infection". (b)(6) 2015 - the patient underwent a vct scan found "hernia involving the right anterolateral abdominal wall lateral to the expected rectus abdominus position. Defect measures about 2. 9 cm ap x 4. 7 cm craniocaudal. There is some unobstructed appearing small bowel which traverses the dissection. The presence of the surgical mesh medial to the defect is suspected". (b)(6) 2015 - the patient visited the surgeon who stated ¿given the fact that the small bowel is chronically incarcerated within the lateral hernia, i think he should have this repaired. I would do a ventralex patch with maybe even a phasix overlay". (b)(6) 2015 - the patient presented for surgery; the surgeon reported the need for this surgery as stemming from "postoperative course stormy with infection" subsequent to the earlier surgery. A ct scan which revealed that the hernia ¿contained small bowel, but it was not obstructed". The surgeon was concerned that the bowel was "in danger of strangulation," and so this surgery was advised. After the surgeon made the initial incision, the surgeon became "suspicious that there was either retained suture or possibly mesh in place," causing the palpable "subcutaneous mass" which was observed. ¿we then almost immediately encountered small bowel right underneath the skin. We then dissected the small bowel away from the fascia edges. Small enterorrhaphy was repaired with 4-0 vicryl. No mucosal violation occurred. This was because of the severe adhesions¿ ¿we did identify what appeared to be a tissue-coated mesh more medially. This was left intact. The hernia appeared to be just lateral to the edge of the mesh". "rather than tear out the entire abdominal wall which was intact by vct scan and palpation, i elected to continue to take down the adhesions of the small bowel until i prepared an intraabdominal space to accommodate a 7 cm mesh patch. The defect was 3 x 2¿. "the (unspecified bard/davol) ventralex patch was then inserted easily and fit very nicely. The edges of the fascia were then approximated to the ventralex patch in a circumferential fashion with interrupted 4-0 vicryl". (b)(6) 2015 and on (b)(6) 2016 ¿ patient returned for follow-up, notes for both visits indicate that the "hernia was doing well". (b)(6) 2016 ¿ the patient returned, complaining of "intermittent discomfort on the right side. The surgeon examined thoroughly. And he has induration related to his surgery", which was not unexpected according to the surgeon. The surgeon recommended to follow-up after 3 months if the problem persisted. (b)(6) 2019 - the patient presented to the emergency department with abdominal pain, nausea and vomiting. A ct scan "confirmed the dilated loops of bowel in the right mid to lower abdomen. Findings were concerning for at least a partial small bowel obstruction. Surgery was indicated". (b)(6) 2019 ¿ the surgeon performed an "exploratory laparotomy with lysis of adhesions, partial small bowel resection and anastomosis; explantation of foreign body mesh; and repair of recurrent incisional hernia with mesh. " the "postoperative diagnoses" included "small bowel obstruction recurrent incisional hernia. " "extensive adhesions between the small intestine and existing abdominal mesh from previous hernia repairs. There was a particularly tight area upon which the bowel appeared to be twisted. There were several additional adhesions between the small bowel along its entire length". The surgeon found it necessary to resection quite a length of the patient¿s intestine, and also removed the "remaining existing mesh from the abdominal wall". "upon entering the wound, adhesions were encountered. These were more dense on the right side of the abdominal wall in the location of the patient's prior surgeries. The fascia was controlled using kocher clamps as sharp dissection was used to divide the adhesions between the small intestine and existing mesh. There was an area where the adhesions were so dense that the mesh was carved off the abdominal wall and left on the bowel¿. ¿there were additional adhesions between loops of bowel and mesentery which were divided, more significant in the right lower quadrant. Attention was focused on the recurrent incisional hernia. The remaining pieces of mesh were removed using cautery and sharp dissection. This explanted mesh was also sent for gross analysis. The hernia defect measured approximately 8 x 5 cm. A 10 x 15 cm bard/davol phasix st mesh was chosen to use in the hernia repair". (b)(6) 2019 ¿ the patient was seen for a post-operative follow up; the surgeon noted the patient was "doing well," but ordered an antibiotic due to the patient's "history of infections". (b)(6) 2019 ¿ the patient indicated a need for three percocets a day to manage pain, as well as noting that "a couple of times he has had pretty sharp pain," and also experiencing "some drainage" from the wound. The surgeon¿s "final diagnosis" included "small intestinal mucosa with focal chronic inflammation, submucosal congested vessels, chronic inflammation and giant cell reaction associated with surgical mesh and serosal adhesions". (b)(6) 2019 - the patient reported for a subsequent follow up, and noted pain in the right testicle, which increases throughout the day. The surgical wound was healing well, but the surgeon concluded that the patient was suffering from another hernia, "small to medium inguinal hernia on the right, [ with a] possible small hernia on the left side. " the patient was "not interested in having this repaired at this time," but would call the surgeon when ready. (b)(6) 2019 - the patient visited the surgeon to discuss the most recent hernias who noted that the patient "actually has bilateral hernias with the right hernia slightly larger on exam. " conservative and surgical treatment options were discussed, and the patient opted once again for surgery.
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Manufacturer (Section D)
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
MDR Report Key11382199
MDR Text Key244175089
Report Number1213643-2021-01322
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA077
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2021 Patient Sequence Number: 1