MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number 850-411

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

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Insufficient Information (4580)

Event Date 03/16/2017

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx ii sling was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; thigh pain; other pain: chest pain ; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: laparoscopic hysterectomy and right salpingectomy with division of adhesions performed.On (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: investigate cause of chest pain which started in (b)(6) 2017.On (b)(6) 2018 the patient underwent further surgery under general anesthesia for the following purpose: removal surgery due to movement of mesh and severe foreign body response.On an unspecified date the patient underwent further surgery under general anesthesia for the following purpose: looking for alternative treatment options due to anxiety avoiding another operation - to remove thyroid.

Manufacturer Narrative

(b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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.

Manufacturer Narrative

Block a1: (b)(4).Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.Block h10: the complainant indicated that the device is not available for return; 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.Correction: a previous report for this patient and device has been sent under mfr report # 3005099803-2021-00091.

Event Description

It was reported to boston scientific corporation that an obtryx ii sling was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); back pain; vaginal pain; pelvic pain; thigh pain; other pain: chest pain ; painful intercourse; inability to have intercourse; offensive vaginal discharge; difficulties with bowel motions; incontinence not present before implant; recurrent incontinence; damage; psychiatric injury surgical interventions: on (b)(6) 2017 the patient underwent further surgery under general anesthesia for the following purpose: laparoscopic hysterectomy and right salpingectomy with division of adhesions performed.On (b)(6)2017 the patient underwent further surgery under general anesthesia for the following purpose: investigate cause of chest pain which started in (b)(6) 2017.On (b)(6) 2018 the patient underwent further surgery under general anesthesia for the following purpose: removal surgery due to movement of mesh and severe foreign body response.On an unspecified date the patient underwent further surgery under general anesthesia for the following purpose: looking for alternative treatment options due to anxiety avoiding another operation - to remove thyroid.

• Brand Name: OBTRYX II SYSTEM - CURVED
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 12930856
• MDR Text Key: 286919199
• Report Number: 3005099803-2021-07092
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 850-411
• Device Catalogue Number: 850-411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 89 KG