MAUDE Adverse Event Report: ALLERGAN (MEDFORD) SERI SURGICAL SCAFFOLD (US); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number SCF10X25AGEN

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 8/20/2015.The event of inadequate tissue ingrowth is a physiological complication, and analysis of the device generally does not assist allergan in determining a probable cause for this event.The physician discarded the device when it was explanted, and it is no longer available for return.Therefore, allergan will not receive the device, and no analysis or testing will be done.Device labeling addresses the reported event of inadequate tissue ingrowth as follows: "seri surgical scaffold must be placed in maximum possible contact with healthy well-vascularized tissue to encourage ingrowth and tissue remodeling." these events are being reported because medical intervention was required, although device-relatedness has not been established.

Event Description

Healthcare professional reported implantation of seri surgical scaffold on (b)(6) 2015 during revision to left side mastectomy reconstruction.On (b)(6) 2015, during a cosmetic revision procedure, the device was discovered to be "100% unincorporated" and removed.The healthcare professional believes insufficient vascularization in the patient tissue after the reconstruction may have contributed to the lack of device incorporation, and the unincorporated scaffold device may have contributed to rupture of the breast implant.Both devices were removed on (b)(6) 2015, and the explanted scaffold was discarded after removal.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer (Section G): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer Contact: krista alvarado ; 301 w howard lane; suite 100; austin, TX 78753 ; 5128132638
• MDR Report Key: 5021064
• MDR Text Key: 23696772
• Report Number: 8020862-2015-00001
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P14091601A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STYLE 15-421 BREAST IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR