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 Integrity Problem (2978)

Patient Problems Abscess (1690); Erosion (1750); Discomfort (2330); Urethral Stenosis/Stricture (4501)

Event Date 03/25/2009

Event Type  Injury  

Manufacturer Narrative

Date of event: 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 mesh was implanted.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.The implanting and explanting surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit device was implanted into the patient during an anterior bilateral sacrospinous ligament fixation using the pinnacle device and bilateral ligament fixation posterior repair procedure performed on (b)(6) 2009, for the treatment of cystocele, rectocele, enterocele and symptomatic pelvic relaxation.Reportedly, the patient was transferred to the recovery room in a good condition.After the procedure, the patient's vaginal mesh was exposed, necessitating the need for a vaginal mesh excision on (b)(6) 2012.The surgeon saw an approximately 2mm spot of anterior vaginal exposure in the patient during surgery and it was then removed.The patient's left side, near the introitus, was found to have a significant mesh exposure.This region was also removed, measuring around 1cm by 1.5cm.Additionally, the patient had a minor stricture at the apex of her vagina that was somewhat off to the left of the midline.During palpation, there was noted to be nodule consistent with clumping of the mesh.The area was opened, and the mesh was then made visible and cut.In order to clear this out, a 2-cm incision was performed.There was good hemostasis present.Following the application of 3-0 monocryl, an estrogen-infused vaginal pack was applied.According to reports, the patient was sent to the recovery area in good condition.The patient underwent another vaginal mesh excision on (b)(6) 2013 for the treatment of exposure.A section of mesh exposure was noted at the top of her vagina along with another area of exposure closer to the introitus.The mesh was removed along its edges and at the region closest to the introitus.The mesh was exposed, then trimmed back and closed.A vaginal pack was inserted once good hemostasis was observed.According to reports, the patient was moved in good condition to the recovery area.On (b)(6) 2016, the patient underwent another surgery to excise vaginal mesh due to mesh exposure.During visualization of the vaginal area, a 2mm exposure of mesh was noted on the left mid portion if the vagina.This was excised.Reportedly, the patient also had an exposure of the sub-urethral sling which was removed.There was noted to be a small abscess pocket that was lavaged.There was no longer palpable mesh along the sub-urethral sling.A good hemostasis was noted, and the patient was transferred to recovery room in a good condition.

Manufacturer Narrative

Block h2: correction b5 narrative updated h6 patient code added e2311 (discomfort) since patient has experienced tenderness.Block b3 date of event: 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 mesh was implanted.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implanting and explanting surgeon is: dr.(b)(6).Block h6: patient code e172001, e1307 and e2006 capture the reportable events of abscess, urethral stricture and exposure of mesh.Impact code f1905 captures the reportable event of partial removal of mesh.Impact code f1903 captures the reportable event of mesh removal.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit device was implanted into the patient during an anterior bilateral sacrospinous ligament fixation using the pinnacle device and bilateral ligament fixation posterior repair using a non-bsc mesh procedure performed on (b)(6) 2009, for the treatment of cystocele, rectocele, enterocele and symptomatic pelvic relaxation.Reportedly, the patient was transferred to the recovery room in a good condition.After the procedure, the patient's vaginal mesh was exposed, necessitating the need for a vaginal mesh excision on (b)(6), 2012.The surgeon saw an approximately 2mm spot of anterior vaginal exposure in the patient during surgery and it was then removed.The patient's left side, near the introitus, was found to have a significant mesh exposure.This region was also removed, measuring around 1cm by 1.5cm.Additionally, the patient had a minor stricture at the apex of her vagina that was somewhat off to the left of the midline.It has been tender in the past.During palpation, there was noted to be nodule consistent with clumping of the mesh.The area was opened, and the mesh was then made visible and cut.In order to clear this out, a 2-cm incision was performed.There was good hemostasis present.Following the application of 3-0 monocryl, an estrogen-infused vaginal pack was applied.According to reports, the patient was sent to the recovery area in good condition.The patient underwent another vaginal mesh excision on (b)(6), 2013 for the treatment of vaginal mesh exposure.A section of mesh exposure was noted at the top of her vagina along with another area of exposure closer to the introitus.The mesh was removed along its edges and at the region closest to the introitus.The mesh was exposed, then trimmed back and closed.A vaginal pack was inserted once good hemostasis was observed.According to reports, the patient was moved in good condition to the recovery area.On (b)(6), 2016, the patient underwent another surgery to excise vaginal mesh due to mesh exposure.During visualization of the vaginal area, a 2mm exposure of mesh was noted on the left mid portion of the vagina.This was excised.Reportedly, the patient also had an exposure of the sub-urethral sling which was removed.There was noted to be a small abscess pocket that was lavaged.There was no longer palpable mesh along the sub-urethral sling.A good hemostasis was noted, and the patient was transferred to recovery room in a good condition.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15105901
• MDR Text Key: 296612480
• Report Number: 3005099803-2022-04081
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female