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

Catalog Number SCF5X15AGEN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pocket Erosion (2013)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 12/14/2015.The event of extrusion 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 extrusion as follows: "adverse reactions are those typically associated with surgically implantable materials, including infection, inflammation, adhesion formation, fistula formation, and extrusion.".

Event Description

Healthcare professional reported implantation of seri surgical scaffold in the left breast supporting mammaplasty.Approximately 8 months post-implantation, patient presented with an "opening in the skin" and the scaffold was "coming out of the medial portion of the breast".The physician indicated the patient's body was "rejecting" the seri.The patient required removal of the device and the concomitant breast implant at that time.The device will not be returned.

Manufacturer Narrative

Lab analysis results: stage i detailed microscopy be performed to document the morphology of the fibers.Comparison of pore sizes of an exemplar seri® scaffold and product received.Measurements were performed using imagej.Images were acquired at 50x.Comparison of woven fiber diameters of an exemplar seri scaffold and product received.Measurements were performed using imagej.Images were acquired at 50x.Comparison of knit patterns of an exemplar seri scaffold and product received.Images were acquired at 50x.Many portions of the mesh appeared like an exemplar seri scaffold.Little to no tissue or biofilm was present on product received.Stage iii ball burst testing to determine the mechanical properties of the retrieved scaffold.The specimen was loaded onto the ball burst fixture and tightened.The torques applied to the screws in the fixture were measured as 1.830 lb-in (0.207 n-m) and 1.897 lb-in (0.214 n-m).Conclusions: many portions of the mesh appeared like an exemplar seri scaffold.Some areas did demonstrate frayed/torn fibers.Little to no tissue or biofilm was incorporated within the received scaffold.Burst testing of pr #(b)(4) resulted in lower maximum load, burst strength, and burst stiffness of the returned scaffold compared with exemplar seri scaffolds tested previously by allergan and exponent.The max load and burst strength were approximately 2.5x lower.The burst stiffness was approximately 2x lower.

Event Description

Device has been returned.

• 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: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5293004
• MDR Text Key: 33390797
• Report Number: 8020862-2015-00040
• 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
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

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 Expiration Date: 03/31/2017
• Device Catalogue Number: SCF5X15AGEN
• Device Lot Number: P14022601A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• 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: ALLERGAN 15-421 SILICONE GEL IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR