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

Model Number UNK558

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

Patient Problems Incontinence (1928); Neuropathy (1983); Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient was implanted with an uphold lite mesh as a participant in the study of uterine prolapse procedures - randomized trial (super study).It was reported to boston scientific corporation that the patient experienced fecal incontinence and urge incontinence prior to procedure (since (b)(6) 2014); however, the fecal incontinence and urge incontinence were reported to be worsening since the surgery and were unresolved as of the patient's last visit on (b)(6) 2014.These events were assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".In addition, the patient experienced a neuromuscular disorder starting (b)(6) 2014, for which the patient takes over-the-counter medications.This event was unresolved as of the patient's last visit on (b)(6) 2014.This event was assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".On october 24, 2014 the patient experienced a lower urinary tract infection (uti) and sought medical attention.The event resolved october 29, 2014.This event was assessed as "moderate" in severity, and relation to the device/procedure was assessed as "possible".

Manufacturer Narrative

Pt age: the patient's age is unknown; however, the patient was over 21 years of age.This event was also reported to the fda in a ps130044 uphold lite 522 postmarket study status report.(b)(4).The device was implanted and will not 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

On (b)(6) 2014, the patient was implanted with an uphold lite mesh as a participant in the study of uterine prolapse procedures - randomized trial (super study).It was reported to boston scientific corporation that the patient experienced fecal incontinence and urge incontinence prior to procedure (since (b)(6) 2014); however, the fecal incontinence and urge incontinence were reported to be worsening since the surgery and were unresolved as of the patient's last visit on (b)(6) 2014.These events were assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".In addition, the patient experienced a neuromuscular disorder starting (b)(6) 2014, for which the patient takes over-the-counter medications.This event was unresolved as of the patient's last visit on (b)(6) 2014.This event was assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".On (b)(6) 2014 the patient experienced a lower urinary tract infection (uti) and sought medical attention.The event resolved (b)(6) 2014.This event was assessed as "moderate" in severity, and relation to the device/procedure was assessed as "possible".Additional information march 17, 2015.The "neuromuscular disorder" was lower back pain.

Event Description

On (b)(6) 2014, the patient was implanted with an uphold lite mesh as a participant in the study of uterine prolapse procedures - randomized trial (super study).It was reported to boston scientific corporation that the patient experienced fecal incontinence and urge incontinence prior to procedure (since (b)(6) 2014); however, the fecal incontinence and urge incontinence were reported to be worsening since the surgery and were unresolved as of the patient's last visit on (b)(6) 2014.These events were assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".In addition, the patient experienced a neuromuscular disorder starting (b)(6) 2014, for which the patient takes over-the-counter medications.This event was unresolved as of the patient's last visit on (b)(6) 2014.This event was assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".On (b)(6) 2014 the patient experienced a lower urinary tract infection (uti) and sought medical attention.The event resolved (b)(6) 2014.This event was assessed as "moderate" in severity, and relation to the device/procedure was assessed as "possible".Additional information march 17, 2015.The "neuromuscular disorder" was lower back pain.Additional information august 5, 2015.The fecal incontinence resolved on (b)(6) 2015.The neuromuscular disorder (lower back pain) resolved on (b)(6) 2014.Urge incontinence still ongoing as of last visit (b)(6) 2015.The patient also had urinary tract infections (symptomatic, with no culture) on (b)(6) 2014 resolving on (b)(6) 2014, and on (b)(6) 2014 resolving on (b)(6) 2014.These were assessed by the investigation as possibly related to the device/procedure and moderate in severity.The patient also experienced pelvic pain and hydronephrosis starting (b)(6) 2015.On (b)(6) 2015, the patient underwent cystoscopy, left retrograde pyelogram and left ureteral stent placement.The patient had a ureteral kink/injury with unknown start date and the status of the patient's hydronephrosis following the (b)(6) 2015 procedure is listed as an "other adverse event"; both of these events are listed as "assumed ongoing" as of the last patient visit on (b)(6) 2015.The pelvic pain was also unresolved as of (b)(6) 2015.The patient had another symptomatic lower urinary tract infection (uti) with inconclusive culture starting (b)(6) 2015 and resolving on (b)(6) 2015.

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2014, the patient was implanted with an uphold lite mesh as a participant in the study of (b)(6) trial.It was reported to boston scientific corporation that the patient experienced fecal incontinence and urge incontinence prior to procedure (since (b)(6) 2014); however, the fecal incontinence and urge incontinence were reported to be worsening since the surgery and were unresolved as of the patient's last visit on (b)(6) 2014.These events were assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible." in addition, the patient experienced a neuromuscular disorder starting (b)(6) 2014, for which the patient takes over-the-counter medications.This event was unresolved as of the patient's last visit on (b)(6) 2014.This event was assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible." on (b)(6) 2014, the patient experienced a lower urinary tract infection (uti) and sought medical attention.The event resolved on (b)(6) 2014.This event was assessed as "moderate" in severity, and relation to the device/procedure was assessed as "possible." additional information march 17, 2015.The "neuromuscular disorder" was lower back pain.Additional information august 5, 2015.The fecal incontinence resolved on (b)(6) 2015.The neuromuscular disorder (lower back pain) resolved on (b)(6) 2014.Urge incontinence still ongoing as of last visit on (b)(6) 2015.The patient also had urinary tract infections (symptomatic, with no culture) on (b)(6) 2014 resolving on (b)(6) 2014, and resolving on (b)(6) 2014.These were assessed by the investigation as possibly related to the device/procedure and moderate in severity.The patient also experienced pelvic pain and hydronephrosis starting (b)(6) 2015.On (b)(6) 2015, the patient underwent cystoscopy, left retrograde pyelogram and left ureteral stent placement.The patient had a ureteral kink/injury with unknown start date and the status of the patient's hydronephrosis following the (b)(6) 2015 procedure is listed as an "other adverse event"; both of these events are listed as "assumed ongoing" as of the last patient visit on (b)(6) 2015.The pelvic pain was also unresolved as of (b)(6) 2015.The patient had another symptomatic lower urinary tract infection (uti) with inconclusive culture starting (b)(6) 2015 and resolving on (b)(6) 2015.Additional information august 1, 2016.The (b)(6) 2015, pelvic pain event was resolved on (b)(6) 2015.The (b)(6) 2015, hydronephrosis is listed as resolved as of (b)(6) 2015, the date the ureteral stent was placed.The left ureteral stent was removed on (b)(6) 2015.The urge incontinence was still unresolved as of the patient's last visit on (b)(6) 2016.

Event Description

On (b)(6) 2014, the patient was implanted with an uphold lite mesh as a participant in the study of uterine prolapse procedures - randomized trial (super study).It was reported to boston scientific corporation that the patient experienced fecal incontinence and urge incontinence prior to procedure (since (b)(6) 2014); however, the fecal incontinence and urge incontinence were reported to be worsening since the surgery and were unresolved as of the patient's last visit on (b)(6) 2014.These events were assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".In addition, the patient experienced a neuromuscular disorder starting (b)(6) 2014, for which the patient takes over-the-counter medications.This event was unresolved as of the patient's last visit on (b)(6) 2014.This event was assessed as "mild" in severity, and relation to the device/procedure was assessed as "possible".On (b)(6) 2014 the patient experienced a lower urinary tract infection (uti) and sought medical attention.The event resolved (b)(6) 2014.This event was assessed as "moderate" in severity, and relation to the device/procedure was assessed as "possible".Additional information march 17, 2015.The "neuromuscular disorder" was lower back pain.Additional information august 5, 2015 the fecal incontinence resolved on (b)(6) 2015.The neuromuscular disorder (lower back pain) resolved on (b)(6) 2014.Urge incontinence still ongoing as of last visit (b)(6) 2015.The patient also had urinary tract infections (symptomatic, with no culture) on (b)(6) 2014 resolving on (b)(6) 2014.These were assessed by the investigation as possibly related to the device/procedure and moderate in severity.The patient also experienced pelvic pain and hydronephrosis starting (b)(6) 2015.On (b)(6) 2015, the patient underwent cystoscopy, left retrograde pyelogram and left ureteral stent placement.The patient had a ureteral kink/injury with unknown start date and the status of the patient's hydronephrosis following the (b)(6) 2015 procedure is listed as an "other adverse event"; both of these events are listed as "assumed ongoing" as of the last patient visit on (b)(6) 2015.The pelvic pain was also unresolved as of (b)(6) 2015.The patient had another symptomatic lower urinary tract infection (uti) with inconclusive culture starting (b)(6) 2015 and resolving on (b)(6) 2015.Additional information august 1, 2016 the (b)(6) 2015 pelvic pain event was resolved on (b)(6) 2015.The (b)(6) 2015 hydronephrosis is listed as resolved as of (b)(6) 2015, the date the ureteral stent was placed.The left ureteral stent was removed on (b)(6) 2015.The urge incontinence was still unresolved as of the patient's last visit on (b)(6) 2016.Additional information on august 24, 2017.Cipro was prescribed for the (b)(6) 2014 urinary tract infection (uti).Macrobid was prescribed for the (b)(6) 2014 lower urinary tract infection (uti).Bactrim was prescribed for the (b)(6) 2014 uti.Macrobid was prescribd for the (b)(6) 2015 uti.On (b)(6) 2017, the patient experienced left side pain of moderate severity.A urine culture was sent and came back negative, and the event resolved on (b)(6) 2017.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4599947
• MDR Text Key: 18547059
• Report Number: 3005099803-2015-00710
• 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: Other,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2015

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 Model Number: UNK558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 03/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/24/2017
• Supplement Dates FDA Received: 04/12/2015; 08/30/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention