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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Fistula (1862); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Ischemia (1942); Pain (1994); Urinary Tract Infection (2120); Electrolyte Imbalance (2196); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); Weight Changes (2607); No Code Available (3191); Insufficient Information (4580)

Event Date 03/15/2011

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2011, 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 mesh excision surgeries were performed at the (b)(6) hospital in 2014 and (b)(6) hospital in 2017.(b)(4).The excised mesh 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 pinnacle pelvic floor repair kits was implanted into the patient during an anterior vaginal repair with mesh, posterior vaginal repair, sacrospinous colpopexy and cystoscopy procedure performed on (b)(6) 2011.As reported by the patient's attorney, the patient experienced ischemic colitis which was severe enough for her to require a month's inpatient management and tpn (total parenteral nutrition), in which time she lost a lot of weight and became severely malnourished.The patient also had some issues about urinary tract infection but it was largely cleared.The patient experienced bright red rectal bleeding, significant cardiovascular disease, hyponatremia and hypertension.A clostridium infection was also noted but the physician believed it was more likely the ischaemic in nature.Further, the patient had three months of daily right upper and lower quadrant pain.Bowel was then irregular.On (b)(6) 2014, a colonoscopy was performed and findings revealed that internal hemorrhoids were visualized with rectal mucosal prolapse.The mesh was palpable in the mid rectal region.Mesh erosion was evident in the upper vagina with a small sinus tract evident.There were two sessile diminutive polyps in the caecum.There was marked sigmoid diverticular disease present with a degree of luminal narrowing present.Subsequently, the polyps were completely resected.On (b)(6) 2014, the patient underwent transvaginal excision of eroding mesh and anterior resection.On (b)(6) 2016, the patient underwent ultrasound and the patient had sharp pain and tenderness at 6cm mid anterior vaginal wall.Mesh remnant was also noted.The patient had another vaginal mesh excision and partial vaginectomy in (b)(6) 2017.

Manufacturer Narrative

Correction to blocks b5, b7, and h6: patient codes.Block b3 date of event: date of event was approximated to (b)(6) 2011, 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).(b)(6) hospital.The mesh excision surgeries were performed at the (b)(6) hospital in 2014 and (b)(6) hospital in 2017.Block h6: patient codes e2006, e1310, e2326, e2330, e2314, e2328, e1202, and e0509 capture the reportable events of mesh erosion, urinary tract infection, ischemic colitis, pain, small sinus tract evident, luminal narrowing, hyponatremia, and ischemic colitis.The events of sessile diminutive polyps and sigmoid diverticular disease have been removed as these are most likely not related to the mesh.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh 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 pinnacle pelvic floor repair kits was implanted into the patient during an anterior vaginal repair with mesh, posterior vaginal repair, sacrospinous colpopexy and cystoscopy procedure performed on (b)(6) 2011.As reported by the patient's attorney, the patient experienced ischemic colitis which was severe enough for her to require a month's inpatient management and tpn (total parenteral nutrition), in which time she lost a lot of weight and became severely malnourished.The patient also had some issues about urinary tract infection but it was largely cleared.The patient experienced bright red rectal bleeding, and hyponatremia.A clostridium infection was also noted but the physician believed it was more likely the ischaemic in nature.Further, the patient had three months of daily right upper and lower quadrant pain.Bowel was then irregular.On (b)(6) 2014, a colonoscopy was performed and findings revealed that internal hemorrhoids were visualized with rectal mucosal prolapse.The mesh was palpable in the mid rectal region.Mesh erosion was evident in the upper vagina with a small sinus tract evident.There was also luminal narrowing present.On (b)(6) 2014, the patient underwent transvaginal excision of eroding mesh and anterior resection.On (b)(6) 2016, the patient underwent ultrasound and the patient had sharp pain and tenderness at 6cm mid anterior vaginal wall.Mesh remnant was also noted.The patient had another vaginal mesh excision and partial vaginectomy in (b)(6) 2017.

Manufacturer Narrative

Blocks b5, h6: patient codes and h6: impact codes have been updated based on the additional information received on october 19, 2022.Block b3 date of event: date of event was approximated to march 15, 2011, 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.Kar ooi royal brisbane and women's hospital butterfield st.Herston, qld 4029 tel #: +011(613)6368346; +011(613)6368848 fax #: +011(613)6361784 the mesh excision surgeries were performed at the wesley hospital in 2014 and north west private hospital in 2017.Block h6: the following patient codes capture the reportable events below: e2006 - mesh erosion e1310 - urinary tract infection e2326 - sessile diminutive polyps e2330 - pain e2314 - small sinus tract evident e2328 - luminal narrowing e1202 - hyponatremia e0509 - ischemic colitis e2101 - adhesions impact codes f1905 and f1901 capture the events of mesh excision and lysis of adhesions.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kits was implanted into the patient during an anterior vaginal repair with mesh, posterior vaginal repair, sacrospinous colpopexy and cystoscopy procedure performed on march 15, 2011.As reported by the patient's attorney, the patient experienced ischemic colitis which was severe enough for her to require a month's inpatient management and tpn (total parenteral nutrition), in which time she lost a lot of weight and became severely malnourished.The patient also had some issues about urinary tract infection, but it was largely cleared.The patient experienced bright red rectal bleeding, significant cardiovascular disease, hyponatremia and hypertension.A clostridium infection was also noted but the physician believed it was more likely the ischaemic in nature.Further, the patient had three months of daily right upper and lower quadrant pain.Bowel was then irregular.On april 1, 2014, a colonoscopy was performed, and findings revealed that internal hemorrhoids were visualized with rectal mucosal prolapse.The mesh was palpable in the mid rectal region.Mesh erosion was evident in the upper vagina with a small sinus tract evident.There were two sessile diminutive polyps in the caecum.There was marked sigmoid diverticular disease present with a degree of luminal narrowing present.Subsequently, the polyps were completely resected.On november 13, 2014, the patient underwent transvaginal excision of eroding mesh and anterior resection.On september 19, 2016, the patient underwent ultrasound and the patient had sharp pain and tenderness at 6cm mid anterior vaginal wall.Mesh remnant was also noted.The patient had another vaginal mesh excision and partial vaginectomy on january 24, 2017.**additional information received on october 19, 2022: on august 25, 2014, the patient underwent lysis of adhesions.Findings included adhesions and pelvic organ prolapse remained despite of upper adhesions.On january 24, 2017, the patient had an eua (examination under anesthesia), excision of tag, excision of vaginal mesh and partial vaginectomy.Findings noted at that time included erosion affected polypropylene mesh anterior vaginal - wall/vaginal vault, skin tags and hemorrhoids.

• 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11139207
• MDR Text Key: 225748249
• Report Number: 3005099803-2021-00012
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Model Number: M0068317050
• Device Catalogue Number: 831-705
• Device Lot Number: 1ML0070801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female