MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS SPARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403656

Device Problem Difficult To Position (1467)

Patient Problem Incontinence (1928)

Event Date 12/01/2015

Event Type  Injury  

Event Description

It was reported that after a sparc was implanted, the patient was still completely incontinent.The physician recalled that at the time of implant, the sling "looked a little loose." the physician used adjustment sutures to try and tighten the sling, and thought it had tightened to the appropriate tension.Due to the continued incontinence, the patient was brought back to the operating room on (b)(6) 2015.Upon opening the incision and dissection to expose the sling, it appeared there was more than an average amount of space between the urethra and the sling.The physician determined the best option would be to remove what she could with minimal tissue disruption and place a new sparc sling.The new sling was implanted with no issues or complications, and looked to be in excellent position with appropriate tensioning at the end of the case.No further patient complications were reported related to this device.Related to manufacturer report #: 3011770902-2015-00109.

• Brand Name: AMS SPARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5333083
• MDR Text Key: 34638523
• Report Number: 3011770902-2015-00109
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2018
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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
• Treatment: NATIVE TISSUE CYSTOCELE REPAIR
• Patient Outcome(s): Required Intervention