MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PFR KIT PINNACLE LITE ANTERIOR / APICAL; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number M0068317140

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Discomfort (2330); Injury (2348); No Code Available (3191); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 02/28/2012

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The surgeon who excised the mesh is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure 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 a pelvic floor repair kit pinnacle lite anterior/ apical device was implanted during an anterior pinnacle, cystoscopy and posterior colporrhaphy procedure performed on (b)(6) 2012 to treat prolapse.As reported by the patient's attorney, during the procedure, it was observed that the patient experienced cystocele, rectocele and enterocele.On (b)(6) 2012, the patient underwent repair of urethrocele, tension-free vaginal tape (tvt) insertion, cystoscopy and sis patch to assist with healing.In addition, the findings were urethrocele++ and mesh exposure left fornix 3cm x 3cm.Since then, the patient has had increasing discomfort which she described as a throbbing, swollen feeling in the vagina and in the bones of her pelvis, and sometimes the pain radiates to the upper thigh and into the lower back.She also mentioned that intercourse was impossible due to terrible pain.Reportedly, she was sexually active before the problem arose.The patient's bladder was fine, however, she had some discomfort in the rectum and flatulence.Furthermore, the physician stated that the patient had these symptoms to some degree prior to her operations and no cause has been found.During the vaginal examination on (b)(6) 2013, it was observed that a 1mm piece of mesh exposed close to the vault in the midline and it was quite tender.With palpation over the arms of mesh tha lead down to the sacrospinous ligament on each side there was an exquisite tenderness.The mesh was not tight.The attachment of the mesh to the white line was not evident at this point and there was no tenderness at the side walls.On (b)(6) 2013, the patient was examined under anesthetic and found that a suture was projecting at the vault but no sign of actual exposed mesh.So, the suture was removed, and a ridge of scar tissue underlying it was seen and was also excised.Moreover, there was a little bit of mesh in the base of that.The overall excision length was 1.5cm, then, 40mg depomedrol in 20ml marcain was injected into the arms of the mesh, this was to treat pain and dyspareunia.On (b)(6) 2013, the patient had an examination under anesthetic and injection of 40mg depomedrol in 20ml marcain, this was to treat pain that emanates from nerve ingrowth into the uphold arms.

Event Description

It was reported to boston scientific corporation that a pelvic floor repair kit pinnacle lite anterior/ apical device was implanted during an anterior pinnacle, cystoscopy and posterior colporrhaphy procedure performed on (b)(6) 2012 to treat prolapse.As reported by the patient's attorney, during the procedure, it was observed that the patient experienced cystocele, rectocele and enterocele.Following the procedure, the patient developed de novo stress urinary incontinence and some discomfort, and mesh exposure was noted.On (b)(6) 2012, the patient underwent repair of urethrocele, tension-free vaginal tape (tvt) insertion, cystoscopy and sis patch to assist with healing.In addition, the findings were urethrocele++ and mesh exposure left fornix 3cm x 3cm.Since then, the patient has had increasing discomfort which she described as a throbbing, swollen feeling in the vagina and in the bones of her pelvis, and sometimes the pain radiates to the upper thigh and into the lower back.She also mentioned that intercourse was impossible due to terrible pain.Reportedly, she was sexually active before the problem arose.The patient's bladder was fine, however, she had some discomfort in the rectum and flatulence.Furthermore, the physician stated that the patient had these symptoms to some degree prior to her operations and no cause has been found.During the vaginal examination on (b)(6) 2013, it was observed that a 1mm piece of mesh exposed close to the vault in the midline and it was quite tender.With palpation over the arms of mesh tha lead down to the sacrospinous ligament on each side there was an exquisite tenderness.The mesh was not tight.The attachment of the mesh to the white line was not evident at this point and there was no tenderness at the side walls.On (b)(6) 2013, the patient was examined under anesthetic and found that a suture was projecting at the vault but no sign of actual exposed mesh.So, the suture was removed, and a ridge of scar tissue underlying it was seen and was also excised.Moreover, there was a little bit of mesh in the base of that.The overall excision length was 1.5cm, then, 40mg depomedrol in 20ml marcain was injected into the arms of the mesh, this was to treat pain and dyspareunia.On (b)(6) 2013, the patient had an examination under anesthetic and injection of 40mg depomedrol in 20ml marcain, this was to treat pain that emanates from nerve ingrowth into the uphold arms.

Manufacturer Narrative

Correction to blocks b5 and h6 - the event of urinary incontinence was added to report de novo stress urinary incontinence as one of the patient's symptoms.Block b3 date of event: date of event was approximated to (b)(6) 2012, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The surgeon who excised the mesh is: dr.(b)(6).Block h6: patient codes e2006, e1715, e0123, e2330, and e2401 capture the reportable events of erosion, scar tissue, nerve damage, pain, and cyst, respectively.Impact code f19 captures the reportable event of mesh removal surgery.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, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: PFR KIT PINNACLE LITE ANTERIOR / APICAL
• 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: 11133784
• MDR Text Key: 226007505
• Report Number: 3005099803-2021-00018
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K103426
• 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: 02/11/2021

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
• Device Expiration Date: 06/30/2014
• Device Model Number: M0068317140
• Device Catalogue Number: 831-714
• Device Lot Number: ML00000179
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR