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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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BOSTON SCIENTIFIC CORPORATION PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN Back to Search Results
Model Number M0068317050
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Purulent Discharge (1812); Fistula (1862); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475)
Event Date 11/25/2019
Event Type  Injury  
Manufacturer Narrative
(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 an obtryx system - halo and pinnacle, anterior apical were implanted into the patient during a anterior colporrhaphy repair of cyctocele + colpopexy vaginal + insertion of mesh procedure performed on (b)(6) 2009 to treat anterior cystocele with prolapse and stress urinary incontinence.After the implantation, the patient experienced urinary retention, recurrenct uti, disorder of bladder, herniation of rectum into vagina and stress incontinence.Patient was also taking numerous medications.On (b)(6) 2019, the patient underwent surgery for removal of suburethral mesh, urethrolysis, female urethral reconstruction.Postoperatively, the patient was diagnosed with urethral diverticulum.Boston scientific has been unable to obtain additional information regarding the event to date.
 
Manufacturer Narrative
Block e1: this event was reported by the patient's legal representation.The implant surgeons are: dr.(b)(6).Block h6: patient codes e2006, e1309, e1310, e2314 and impact code f19 capture the reportable events of erosion, urinary retention, urinary tract infection, fistula and additional 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.
 
Event Description
It was reported to boston scientific corporation that an obtryx system - halo and pinnacle, anterior apical were implanted into the patient during a anterior colporrhaphy repair of cystocele + colpopexy vaginal + insertion of mesh procedure performed on (b)(6) 2009 to treat anterior cystocele with prolapse and stress urinary incontinence.After the implantation, since her sling was placed in 2009, the patient has been in urinary retention.In-office urethral dilation after the procedure was without benefit.She was able to spontaneously void with straining but experienced recurrent urinary tract infections due to incomplete bladder emptying.In 2017, the patient started self-catheterizing.On (b)(6) 2019 the patient was evaluated for the urinary retention and recurrent urinary tract infections at which time she was self-catheterizing 2-3 times per day.Examination revealed a small herniation of rectum into vagina, and the physician noted that the sling had probably been placed too tight resulting in the urinary retention.Urodynamics study was planned to assess bladder function and sling incision under sedation was planned.Patient was also taking numerous medications.On (b)(6) 2019, the patient underwent surgery for takedown of her sling and mobilization of her urethra.During the procedure, an epithelial lined diverticulum cavity (also referred to as urethral fistula tract) was noted in the urethra, slightly to the right of midline near the bladder neck.This was filled with purulent fluid and the sling was going through the cavity.The suburethral mesh was removed, urethrolysis, and female urethral reconstruction were performed to address the diverticulum.The patient was treated with antibiotics and a foley catheter was placed for 2 weeks.
 
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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 Key11427195
MDR Text Key238609052
Report Number3005099803-2021-00968
Device Sequence Number1
Product Code OTP
Combination Product (y/n)N
PMA/PMN Number
K071957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2009
Device Model NumberM0068317050
Device Catalogue Number831-705
Device Lot Number0ML8111902
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age58 YR
Patient Weight73
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