MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317050

Device Problem Material Twisted/Bent (2981)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Erosion (1750); Extravasation (1842); Fever (1858); Flatus (1865); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Obstruction/Occlusion (2422); Confusion/ Disorientation (2553); Fibrosis (3167); Constipation (3274); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Fecal Incontinence (4571)

Event Date 02/23/2009

Event Type  Injury  

Manufacturer Narrative

The exact event onset date is unknown.The provided event date of (b)(6) 2009 was chosen as a best estimate based on the date of the sling was implanted.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that the patient was diagnosed with cystocele, rectocele, vaginal vault prolapse, and stress urinary incontinence.On (b)(6) 2009, she was implanted with an advantage fit system and pinnacle pelvic floor repair kit during an anterior repair with insertion of mesh, vaginal vault suspension with insertion of mesh to the sacrospinous ligaments, posterior colporrhaphy by plication of the fascia of denonvilliers, placement of synthetic sub-urethral sling, and cystourethroscopy procedure.Operative findings note that evaluation under anesthesia revealed cystocele laying at the introitus.In addition, when this was elevated, a rectocele and about 1cm of scarring from her prior deliveries were seen.The apex of the vagina had a grade 1 prolapse.During the procedure, two cystourethroscopies were performed, and showed a normal appearing urethra, and the bladder had mild trabeculations.Moreover, there was no tumor, stone, or erythema.There was also good reflux of urine seen from the right-hand side with the first cystoscopy.It was repeated after closure just to make sure that the left side was indeed effluxing urine, and it was easy to see given the pyridium stained nature of her urine.There was no evidence of any trocar injury to the bladder during the procedure.On (b)(6) 2020, the patient was presented with mesh problems that had begun 1 year prior.These symptoms were located vaginally and reported to be severe and occurred daily.Furthermore, the aggravating factors include sitting, walking, and standing, and was relieved with lying down.The patient stated that the symptoms were chronic and uncontrolled.She experienced right-sided constant burning pain, as well as, a superimposed intermittent right-sided sharp pain just lateral to the pubic symphysis.She had been experiencing similar pain on her left side with the same characteristics.The patient was diagnosed with mesh exposure in 2019 but had not undergone any revisions or removals.Also, she had chronic discharge and right vaginal wall soreness.Her activities of daily living (adls) were greatly affected such as walking, housework, lifting objects, and exercise.Additionally, the patient mentioned that she also had incomplete emptying, and she was not sexually active due to severe dyspareunia which started after the surgery in 2009 and had not any intercourse in 11 years.Subsequently, the patient experienced right sided suprapubic pain, and constipation.She had leakage of gas and stool approximately once a month.Exam revealed urethral meatus pain at the periurethral cords, right suprapubic pain, severe vaginal anteriorly at the mesh, bunched and corded exposed mesh, and multiple exposed mesh areas.On (b)(6) 2020, the patient was diagnosed with vaginal pain, bladder pain, suprapubic pain, dyspareunia, exposed mesh, foreign body in vagina, and urethral scarring.She then underwent a bilateral paravaginal dissection, bilateral pararectal dissection, removal of advantage sling, urethral lysis, removal of pinnacle mesh, anterior colporrhaphy, and posterior colporrhaphy.This was a very complicated and very difficult surgery.There was severe scarring, the pinnacle fibers on the right were eroded, and there was an evident vaginal prolapse with a rectocele.The sling was in the right obturator muscle, the bladder wall and lateral to the rectus muscle on the right.The pinnacle mesh was rolled/twisted and folded on the left.The entire advantage sling was removed, and the pinnacle mesh arm on the right was removed from the levators.The patient had a post-operative fever.She was suspected to have atelectasis and was instructed to use an incentive spirometry.On the day of discharge ( (b)(6) 2020), she had no fever for 24 hours.She was tolerating regular diet and ambulating without difficulty prior to discharge.The patient was also instructed on the care and use of her plugged foley catheter.The patient felt comfortable in using her catheter for interval voids.Reportedly, the pathology final diagnoses of the patient were foreign material, pinnacle mesh, and advantage fit mesh removal, fibrosis, chronic inflammation, and foreign body-type giant cell reaction.On (b)(6) 2020, the patient presented to the emergency department (ed) with severe abdominal pain.The symptoms began the night before and progressively worsened overnight to about 9/10 despite receiving dilaudid and fentanyl in the ed.She also experienced sharp pain that came in waves located mainly in the left lower quadrant and suprapubic area.She also had associated nausea and fever which was 100.5 f maximum temperature in the ed.Of note, the patient did have postoperative fever on the day following the surgery which was thought to be a secondary to atelectasis.She did have the vaginal packing and foley catheter in place.The patient also had scant vaginal bleeding/discharge since discharged from hospital.Moreover, the patient had been compliant with postoperative medications including colace and antibiotics.Reportedly, she had positive flatus, and no bowel movement for a few days.Computed tomography (ct) scan of the abdomen and pelvis imaging visualized moderate inflammatory changes in the lower pelvis with partly loculated and incompletely organized air/fluid density.The concern was for a developing abscess versus pelvic hematoma.Her laboratory findings showed anemia and mild leukocytosis.On (b)(6) 2020, the patient underwent evacuation of suspected pelvic hematoma and cystoscopy.The previous anterior vaginal wall suture line was opened, and serosanguinous fluid was evacuated.Suction was used to remove any additional fluid.The fluid did not look like a hematoma fluid and further evaluation was taken with cystoscopy.Cystoscopy was performed and the integrity of the bladder was confirmed.Fluorescein was given and the right ureteric orifice revealed normal jets of green urine.No jets were noted from the left ureteric opening.Urology consult with obtained due to suspicion of a left ureteral injury from removal of the mesh.Urology performed cystoscopy, bilateral retrograde pyelogram, open procedure, left ureteral reimplantation with psoas hitch, and open left ureteral stent placement procedure.Cystoscopy revealed inflammation in the left trigone and left hemi-bladder.The right ureteral orifice was cannulated with a 5 french open-ended catheter.A right retrograde pyelogram was done showing no evidence of injury.The left ureteral orifice was cannulated over a wire.A retrograde pyelogram was done that showed complete extravasation of urine and no obvious proximal left ureteral end.During the exploratory laparotomy, the sigmoid colon off the left was mobilized and some bowel adhesions were taken down, then retraction was placed.Upon dissecting the left ureter, it was found that the distal 3 cm of ureter seemed to have cautery effect.It came up freely and distal ureteral end could not be identified.The ureter was anastomosed to the bladder with psoas hitch.The pathology final diagnosis of the left distal ureter was peri-ureteral inflammation, reactive changes, and focal necrosis, including gangrenous necrosis.The patient's post-operative hospital course was complicated by acute postop psychosis with confusion, which resolved post-operative day #1.By post-operative day #5 her jp drain was removed.She was tolerating regular diet and ambulating without difficulty prior to discharge.On (b)(6) 2020, the day of discharge, the patient was instructed on the care and use of her foley catheter (to be left in place for 10 days per urology).

Manufacturer Narrative

Correction to block b5: to report relevant information surrounding the event that was not included in the previous report but was provided in the medical records.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2009 was chosen as a best estimate based on the date of the sling was implanted.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(6).Dr (b)(6) (explanting surgeon).(b)(6).Block h6: patient codes e2006, e1715, e2101, e2326, e0506, e2330, e1002, e1405, e1309, e2328, e2327, e2313, e0752, and e1311 capture the reportable events of vaginal mesh exposure, sling at the right obturator muscle, the bladder wall and lateral to the rectus muscle, scarring, bowel adhesions, chronic inflammation, hemorrhage, pain (vaginal, bladder, suprapubic), abdominal pain, dyspareunia, urinary retention, trabeculations, focal necrosis, fibrosis, atelectasis, and left ureteral injury.Impact codes f1903, f1901, f2303, f2202, f2203, and f22 captures the reportable event of removal of advantage sling and pinnacle mesh, bilateral paravaginal dissection, bilateral pararectal dissection, urethral lysis, anterior colporrhaphy, posterior colporrhaphy, dilaudid and fentanyl for pain, cystoscopy, and computed tomography (ct) scan.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that the patient was diagnosed with cystocele, rectocele, vaginal vault prolapse, and stress urinary incontinence.On (b)(6) 2009, she was implanted with an advantage fit system and pinnacle pelvic floor repair kit during an anterior repair with insertion of mesh, vaginal vault suspension with insertion of mesh to the sacrospinous ligaments, posterior colporrhaphy by plication of the fascia of denonvilliers, placement of synthetic sub-urethral sling, and cystourethroscopy procedure.Operative findings from the 2009 procedure note that evaluation under anesthesia revealed cystocele laying at the introitus.In addition, when this was elevated, a rectocele and about 1cm of scarring from her prior deliveries were seen.The apex of the vagina had a grade 1 prolapse.During the procedure, two cystourethroscopies were performed, and showed a normal appearing urethra, and the bladder had mild trabeculations.Moreover, there was no tumor, stone, or erythema.There was also good reflux of urine seen from the right-hand side with the first cystoscopy.It was repeated after closure just to make sure that the left side was indeed effluxing urine, and it was easy to see given the pyridium stained nature of her urine.There was no evidence of any trocar injury to the bladder during the procedure.On (b)(6) 2020, the patient was presented with mesh problems that had begun 1 year prior.These symptoms were located vaginally and reported to be severe and occurred daily.Furthermore, the aggravating factors include sitting, walking, and standing, and was relieved with lying down.The patient stated that the symptoms were chronic and uncontrolled.She experienced right-sided constant burning pain, as well as, a superimposed intermittent right-sided sharp pain just lateral to the pubic symphysis.She had been experiencing similar pain on her left side with the same characteristics.The patient was diagnosed with mesh exposure in 2019 but had not undergone any revisions or removals.Also, she had chronic discharge and right vaginal wall soreness.Her activities of daily living (adls) were greatly affected such as walking, housework, lifting objects, and exercise.Additionally, the patient mentioned that she also had incomplete emptying, and she was not sexually active due to severe dyspareunia which started after the surgery in 2009 and had not any intercourse in 11 years.Subsequently, the patient experienced right sided suprapubic pain, and constipation.She had leakage of gas and stool approximately once a month.Exam revealed urethral meatus pain at the periurethral cords, right suprapubic pain, severe vaginal pain anteriorly at the mesh, bunched and corded exposed mesh, and multiple exposed mesh areas.On (b)(6) 2020, the patient was diagnosed with vaginal pain, bladder pain, suprapubic pain, dyspareunia, exposed mesh, foreign body in vagina, and urethral scarring.She then underwent a bilateral paravaginal dissection, bilateral pararectal dissection, removal of advantage sling, urethral lysis, removal of pinnacle mesh, anterior colporrhaphy, and posterior colporrhaphy.This was a very complicated and very difficult surgery as reported by the surgeon in the operative note.There was severe scarring, the pinnacle fibers on the right were eroded, and there was an evident vaginal prolapse with a rectocele.The sling was in the right obturator muscle, the bladder wall and lateral to the rectus muscle on the right.The pinnacle mesh was rolled/twisted and folded on the left.The advantage arms were freed from the muscle tissue, the retropubic space was opened bilaterally to visualize the mesh, progressive dissection completely freed the left sling arm from the bladder wall.The right sling arm was identified and also freed from the fascia and rectus muscles.Traction of the arm elevated the bladder wall.The mesh was followed as it entered the right obturator internus muscle and dissected free.The entire advantage sling was removed.The remaining anterior vaginal wall was opened past the vaginal apex to the posterior vaginal wall and the pinnacle mesh cut in the midline and was dissected cephalad, caudad and laterally initially on the vaginal side and then on the bladder side taking the mesh off the bladder.The right paravaginal space was entered and the pinnacle mesh was dissected laterally as far as possible and the pinnacle mesh was removed initially on the right from the levators as the pararectal space was also opened to remove the pinnacle arm from the pelvic floor muscles.On the left the pinnacle mesh was deeper in the bladder wall and the mesh was folded.The paravaginal space was further opened for exposure as well as the pararectal space as the pinnacle mesh arm was twisted.The pinnacle mesh arm on the right was removed from the levators.The pinnacle mesh was removed.The urethra was repaired with interrupted sutures of #3-0 dexon.The bladder was repaired with interrupted sutures of #2-0 dexon.The anterior vaginal wall was closed with a running suture of #2-0 dexon and the upper posterior vaginal wall was closed with a running suture of #2-0 dexon.The exposure in the anterior vaginal wall was closed with interrupted sutures of #2-0 dexon.There is no mention in the operative report of cystoscopy following repair of the bladder and urethra.The patient had a post-operative fever.She was suspected to have atelectasis and was instructed to use an incentive spirometry.On the day of discharge ((b)(6) 2020), she had no fever for 24 hours.She was tolerating regular diet and ambulating without difficulty prior to discharge.The patient was also instructed on the care and use of her plugged foley catheter.The patient felt comfortable in using her catheter for interval voids.Reportedly, the pathology final diagnoses of the patient were foreign material, pinnacle mesh, and advantage fit mesh removal, fibrosis, chronic inflammation, and foreign body-type giant cell reaction.On (b)(6) 2020, the patient presented to the emergency department (ed) with severe abdominal pain.The symptoms began the night before and progressively worsened overnight to about 9/10 despite receiving dilaudid and fentanyl in the ed.She also experienced sharp pain that came in waves located mainly in the left lower quadrant and suprapubic area.She also had associated nausea and fever which was 100.5 f maximum temperature in the ed.Of note, the patient did have postoperative fever on the day following the surgery which was thought to be a secondary to atelectasis.She did have the vaginal packing and foley catheter in place.The patient also had scant vaginal bleeding/discharge since discharged from hospital.Moreover, the patient had been compliant with postoperative medications including colace and antibiotics.Reportedly, she had positive flatus, and no bowel movement for a few days.Computed tomography (ct) scan of the abdomen and pelvis imaging visualized moderate inflammatory changes in the lower pelvis with partly loculated and incompletely organized air/fluid density.The concern was for a developing abscess versus pelvic hematoma.Her laboratory findings showed anemia and mild leukocytosis.On (b)(6) 2020, the patient underwent evacuation of suspected pelvic hematoma and cystoscopy.The previous anterior vaginal wall suture line was opened, and serosanguinous fluid was evacuated.Suction was used to remove any additional fluid.The fluid did not look like a hematoma fluid and further evaluation was taken with cystoscopy.Cystoscopy was performed and the integrity of the bladder was confirmed.Fluorescein was given and the right ureteric orifice revealed normal jets of green urine.No jets were noted from the left ureteric opening.Urology consult with obtained due to suspicion of a left ureteral injury from removal of the mesh.Urology performed cystoscopy, bilateral retrograde pyelogram, open procedure, left ureteral reimplantation with psoas hitch, and open left ureteral stent placement procedure.Cystoscopy revealed inflammation in the left trigone and left hemi-bladder.The right ureteral orifice was cannulated with a 5 french open-ended catheter.A right retrograde pyelogram was done showing no evidence of injury.The left ureteral orifice was cannulated over a wire.A retrograde pyelogram was done that showed complete extravasation of urine and no obvious proximal left ureteral end.During the exploratory laparotomy, the sigmoid colon off the left was mobilized and some bowel adhesions were taken down, then retraction was placed.Upon dissecting the left ureter, it was found that the distal 3 cm of ureter seemed to have cautery effect.It came up freely and distal ureteral end could not be identified.The ureter was anastomosed to the bladder with psoas hitch.The pathology final diagnosis of the left distal ureter was peri-ureteral inflammation, reactive changes, and focal necrosis, including gangrenous necrosis.The patient's post-operative hospital course was complicated by acute postop psychosis with confusion, which resolved post-operative day #1.By post-operative day #5 her jp drain was removed.She was tolerating regular diet and ambulating without difficulty prior to discharge.On (b)(6) 2020, the day of discharge, the patient was instructed on the care and use of her foley catheter (to be left in place for 10 days per urology).

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12377519
• MDR Text Key: 268471679
• Report Number: 3005099803-2021-04353
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2009
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Device Lot Number: 0ML8111101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR