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| Model Number 1DLMCPH06 |
| Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422); Not Applicable (3189)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).
The initial reporter's complete address is (b)(6).
It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
¿.
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2009 whereby a gore dualmesh® plus biomaterial was implanted.
It was reported the patient alleges the following injuries: abdominal pain, small bowel obstruction, adhesions, multiple hernia recurrences, mesh revision.
Additional event specific information was not provided.
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Manufacturer Narrative
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Added medical history.
Conclusion code remains unchanged.
Added medical record information.
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: operative records detailing the laparoscopic cholecystectomy in 2001 and partial hysterectomy in january 2009, were not provided.
History and physical notes dated on (b)(6) 2009 state: ¿hysterectomy for fibroid (causing urinary tract obstruction) was carried out in january 2009.
She postop was noted to have a seroma.
Recently she has noticed when standing or when transitioning from sitting to standing, a bulge and discomfort in the lower part of her abdomen.
Evaluation was carried out at renaissance ob-gyn and she was referred by (b)(6) for evaluation and concern that a hernia may be present in the incision.
¿ history and physical notes dated on (b)(6) 2009 state: ¿she has a diastasis recti above the naval.
Below the naval, she has a midline incision.
When lying down, there is no palpable mass, but as soon as she begins to tense abdominal muscles/lift shoulders off, there is a large hernia that can be felt emerging below the naval.
This is an easily reducible fascial defect.
Palpation is difficult due to body habitus.
¿ discharge summary for hospital admission on (b)(6) 2009 states: ¿previous hysterectomy, incision and now has a bulge and an incisional hernia has been identified.
She would like this repaired as this causes discomfort with activity and discomfort bulge is beginning to limit her activities.
¿ follow up visit dated on (b)(6) 2009 states: ¿when she moves, she has noticed a small release of fluid from the incision.
Other than that, she has got no difficulties in terms of swelling, fever, no redness or other problems.
She does have longstanding pedal edema for which she is supposed to see dr.
Ferrer.
¿ ¿she is using a binder.
She has a well-healed midline incision.
Staples are present.
There is no cellulitis or evidence of infection.
When she moves onto the table, no hernia is appreciated.
¿ follow up visit dated on (b)(6) 2009 states: ¿she is not using binder anymore.
Staples were removed from intact skin.
The skin edges are well apposed and healing well, at examination with valsalva/abdominal muscle wall tensing, there is expected small bulge from the gore-tex; however, she clearly does not have a hernia.
There is no cellulitis.
There is no drainage.
¿ records pertaining to abdominal procedures between 2009 and 2012 were not provided.
A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.
It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
¿ w.
L.
Gore & associates, inc.
(gore) is submitting this report to comply with 21 c.
F.
R.
Part 803, the medical device reporting regulation.
This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.
Blank fields present on this report include required fields and fields determined to be not applicable.
Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.
This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.
In particular, this report does not constitute an admission by anyone that the product described in this report has any ""defects"" or has ""malfunctioned"".
These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.
This statement should be included with any information or report disclosed to the public under the freedom of information act.
".
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Manufacturer Narrative
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H6: corrected results code.
Conclusion code remains unchanged.
Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: records prior to 2009, including records detailing the hysterectomy mentioned in the 10/12/2009 records, were not provided.
Operative records dated 10/12/2009 indicate the patient underwent repair of an incisional hernia.
¿this is a 48-year-old lady who has previously undergone hysterectomy and now there is an incisional hernia.
¿ findings from the procedure state: ¿what was thought to be a hernia at the naval turns out to be near complete fascial dehiscence with a couple of bridges where the tissue was intact.
The incision was reopened and fascial shards to allow reconstruction with dual mesh was carried out.
¿ the 10/12/2009 records state: ¿time out was observed and then a scalpel was used to create a midline incision where the surgical marker had been used, after it was infiltrated with local.
¿ ¿the hernia sac was encountered and the followed down to the level of the fascia was opened up and as preperitoneal space was opened up it became apparent caudal and distal.
The fascia just had bridges of normal tissue separating the continued ongoing midline dehiscence/hernia.
The incision was completely opened up.
A vicryl mesh was brought into the field and then trimmed and tacked in place to hold abdominal contents in place.
An 18 x 24 cm gore-tex mesh was brought into the field and then trimmed to fit the defect and then utilizing a modified runny technique this was tacked into place to the fascia that was identified on the outside of the vicryl mesh.
¿ the 10/12/2009 records continue: ¿care was taken to ensure that the appropriate side was against the peritoneum once the vicryl has been metabolized away.
There was no tension on the repair.
Tissues were hemostatic.
The area was copiously irrigated.
The irrigant was evacuated away as completely as possible.
Some subcutaneous tissue release was carried out to provide additional layer for closure and eventually after bringing this together with o polysorb suture, 3-0 was used to bring together some additional subcutaneous tissues.
Finally staples were used to bring together the skin edges.
¿ the records confirm a gore dualmesh® plus biomaterial with holes (1dlmcph06/06622659) was implanted during the procedure.
Records between 2009 and 2012 were not provided.
Operative records dated 4/10/2012 indicate the patient underwent lysis of adhesions and complex ventral hernia repair for a diagnosis of ¿small bowel obstruction secondary to incarcerated ventral hernia.
¿ the records state: ¿her previous lower midline incision was opened and this was carried down sharply with electrocautery.
There was noted to be a multiloculated large hernia sac extending to the left of the lower midline with small bowel trapped within it.
The bowel was dusky but still viable.
Adhesions were lysed to facilitate freeing up what appeared to be a chronically incarcerated loop of small bowel with more acute obstructive changes.
Next the abdomen was entered and additional adhesions were lysed to completely free up the small bowel and evaluate the abdominal wall musculature.
¿ the 4/10/2012 operative records continue: ¿the patient's previous mesh repair was visualized inferior to the umbilicus and the recurrence of the hernia was in the entire lower abdomen.
The subcutaneous fat was then mobilized in order to gain better purchase to any available abdominal wall fascia and musculature.
There was a significant lower abdominal defect.
The extraneous hernia sac was excised and sent for permanent section.
There was a total of 4 hernia defects noted in the vicinity of the lower abdomen and most notably one approximately 5 cm in diameter at the very lowest aspect of the abdomen in the suprapubic area, which extended down to the urinary bladder.
Starting with the lower, almost pelvic hernia defect, a 9-cm round parietex composite mesh was chosen.
The lowest aspect of the viable fascia just superior to the urinary bladder was visualized and three o prolene sutures were placed to tent up this structure for better visualization and access.
The absorbatack device was then utilized to fixate the round parietex composite mesh circumferentially over the lower abdominal defect.
¿ the 4/10/2012 operative records state: ¿next a 15 x 10-cm rectangular piece of parietex composite mesh was chosen.
This was tacked in place along the lower half of the defect with the absorbatack and then o prolene sutures were utilized in the upper half in an interrupted mattress fashion, taking good purchase of the fascia for stabilization.
These sutures were tied and the repair appeared sturdy.
The subcutaneous fat was then approximated overlying the mesh with 2-0 vicryl suture.
A 10 flat jackson-pratt drain was then placed through a right lower abdomen stab wound and placed in the subcutaneous location.
An additional layer of interrupted vicryl suture was placed and then finally interrupted vertical mattress nylon sutures to the skin.
¿ the records indicate a non-gore device was used during the procedure.
There was no mention of infection and no mention of device removal during the procedure.
A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time.
It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
¿ w.
L.
Gore & associates, inc.
(gore) is submitting this report to comply with 21 c.
F.
R.
Part 803, the medical device reporting regulation.
This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.
Blank fields present on this report include required fields and fields determined to be not applicable.
Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.
This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.
In particular, this report does not constitute an admission by anyone that the product described in this report has any ""defects"" or has ""malfunctioned"".
These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.
This statement should be included with any information or report disclosed to the public under the freedom of information act.
".
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Manufacturer Narrative
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H6: updated patient codes h6: updated device code h6: updated conclusion codes h6: conclusion code 4316: no term/code available for ¿withdrawn complaint¿ previous patient codes (1994, 2422, 1695, 2240) were reported based on the original complaint and are no longer applicable per gore¿s investigation.
This claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.
No further investigation is required at this time.
Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.
This event will be closed as no problem detected.
The following information was determined from the medical records.
Medical records: the known medical records span september 23, 2009 through april 10, 2012, and not all records received in this time span are relevant to gore® dualmesh® plus biomaterial with holes.
Records from november 12, 2009 through april 09, 2012 were not provided.
Patient information: medical history: uterine fibroma with urinary obstruction.
Hypertension.
Morbid obesity; bmi 46.
Anxiety.
Gastroesophageal reflux disease.
Prior surgical procedures: 2001: laparoscopic cholecystectomy.
2009: partial hysterectomy.
Implant preoperative complaints: (b)(6) 2009: ¿she has a diastasis recti above the naval.
Below the naval, she has a midline incision.
When lying down, there is no palpable mass, but as soon as she begins to tense abdominal muscles/lift shoulders off, there is a large hernia that can be felt emerging below the naval.
This is an easily reducible fascial defect.
Palpation is difficult due to body habitus.
¿ implant procedure: incisional hernia repair.
Implant: gore® dualmesh® plus biomaterial with holes (06622659/1dlmcph06) 18cm x 24cm x 1.
5mm.
Implant date: (b)(6) 2009 [hospitalized (b)(6) 2009 through (b)(6) 2009] description of hernia being treated: ¿what was thought to be a hernia at the naval turns out to be near complete fascial dehiscence with a couple of bridges where the tissue was intact.
The incision was reopened and fascial shards to allow reconstruction with dual mesh was carried out.
¿ ¿the hernia sac was encountered and the followed down to the level of the fascia was opened up and as preperitoneal space was opened up it became apparent caudal and distal.
The fascia just had bridges of normal tissue separating the continued ongoing midline dehiscence/hernia.
¿ implant size and fixation: ¿a vicryl mesh was brought into the field and then trimmed and tacked in place to hold abdominal contents in place.
An 18 x 24 cm gore-tex mesh was brought into the field and then trimmed to fit the defect and then utilizing a modified runny [sic] technique this was tacked into place to the fascia that was identified on the outside of the vicryl mesh.
Care was taken to ensure that the appropriate side was against the peritoneum once the vicryl has been metabolized away.
There was no tension on the repair.
¿ post-operative period: [4 days] (b)(6) 2009: discharge summary: ¿her postop course was notable for passage of flatus on the first postoperative day, she had mild temperature elevation and work up did not reveal any worrisome development.
By the third postoperative day she had had a bowel movement, she demonstrated independence with routine activities of daily living.
Her incision is dry without erythema.
She was felt to be stable for discharged.
She was discharged home in good condition.
¿ post-operative period: [two weeks] (b)(6) 2009: ¿when she moves, she has noticed a small release of fluid from the incision.
Other than that, she has got no difficulties in terms of swelling, fever, no redness or other problems.
She does have longstanding pedal edema for which she is supposed to see dr.
Ferrer.
¿ ¿she is using a binder.
She has a well-healed midline incision.
Staples are present.
There is no cellulitis or evidence of infection.
When she moves onto the table, no hernia is appreciated.
¿ post-operative period: [one month] (b)(6) 2009: ¿she is not using binder anymore.
Staples were removed from intact skin.
The skin edges are well apposed and healing well.
At examination with valsalva/abdominal muscle wall tensing, there is expected small bulge from the gore-tex; however, she clearly does not have a hernia.
There is no cellulitis.
There is no drainage.
¿ relevant medical information: (b)(6) 2012: lysis of adhesions and complex ventral hernia repair for ¿small bowel obstruction secondary to incarcerated ventral hernia.
¿ ¿her previous lower midline incision was opened and this was carried down sharply with electrocautery.
There was noted to be a multiloculated large hernia sac extending to the left of the lower midline with small bowel trapped within it.
The bowel was dusky but still viable.
Adhesions were lysed to facilitate freeing up what appeared to be a chronically incarcerated loop of small bowel with more acute obstructive changes.
Next the abdomen was entered and additional adhesions were lysed to completely free up the small bowel and evaluate the abdominal wall musculature.
The patient's previous mesh repair was visualized inferior to the umbilicus and the recurrence of the hernia was in the entire lower abdomen.
The subcutaneous fat was then mobilized in order to gain better purchase to any available abdominal wall fascia and musculature.
There was a significant lower abdominal defect.
The extraneous hernia sac was excised and sent for permanent section.
There was a total of 4 hernia defects noted in the vicinity of the lower abdomen and most notably one approximately 5 cm in diameter at the very lowest aspect of the abdomen in the suprapubic area, which extended down to the urinary bladder.
Starting with the lower, almost pelvic hernia defect, a 9-cm round parietex composite mesh was chosen.
The lowest aspect of the viable fascia just superior to the urinary bladder was visualized and three 0 prolene sutures were placed to tent up this structure for better visualization and access.
The absorbatack device was then utilized to fixate the round parietex composite mesh circumferentially over the lower abdominal defect.
Next a 15 x 10-cm rectangular piece of parietex composite mesh was chosen.
This was tacked in place along the lower half of the defect with the absorbatack and then 0 prolene sutures were utilized in the upper half in an interrupted mattress fashion, taking good purchase of the fascia for stabilization.
These sutures were tied and the repair appeared sturdy.
The subcutaneous fat was then approximated overlying the mesh with 2-0 vicryl suture.
A 10 flat jackson-pratt drain was then placed through a right lower abdomen stab wound and placed in the subcutaneous location.
An additional layer of interrupted vicryl suture was placed and then finally interrupted vertical mattress nylon sutures to the skin.
¿ the records indicate that the gore device was not explanted and that a second and third, non-gore device, were implanted.
Conclusion: it should be noted that the gore® dualmesh® plus biomaterial with holes instructions for use includes warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.
These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, recurrence, ileus, increased procedure time and related harms, irritation or inflammation, infection, pain, paresthesia, perforation, revision / re-intervention, seroma or hematoma and related harms, wound complications and wound dehiscence.
Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.
Based upon the information received, the device remains in the patient and was not available for evaluation; therefore, a direct product analysis could not be conducted.
Review of the manufacturing records verified that the lot met all pre-release specifications.
The investigation concluded that there is no relationship between the device history record findings and the event.
All available information has been placed on file for use in product surveillance, tracking, trending and follow-up.
Section c1: name: plus antimicrobial product coating.
Manufacturer/compounder: w.
L.
Gore & associates, inc.
Lot number: 06622659.
Additional manufacturer narrative: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (¿g/cm3)].
W.
L.
Gore & associates, inc.
(gore) is submitting this report to comply with 21 c.
F.
R.
Part 803, the medical device reporting regulation.
This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.
Blank fields present on this report include required fields and fields determined to be not applicable.
Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.
This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.
In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".
These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.
This statement should be included with any information or report disclosed to the public under the freedom of information act.
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