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

Catalog Number SCF10X25AGEN

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Capsular Contracture (1761); Erythema (1840); Fever (1858); Inflammation (1932); Local Reaction (2035); Seroma (2069)

Event Date 12/10/2014

Event Type  Injury  

Event Description

Healthcare professional reported implantation of seri and concomitant non-allergan breast implant and non-allergan alloderm brand surgical scaffold on (b)(6) 2014 for tissue support during right side breast reconstruction surgery.Post-implantation, on (b)(6) 2014, patient presented with redness and "little red bumps".Treatment included keflex, cipro, bactrim, and intravenous vancomycin.The device remains implanted and is unavailable for return.

Manufacturer Narrative

Further information regarding event and product details has been requested.No additional information is available at this time.The events of "redness" and "little red bumps" are physiological complications, and analysis of the device generally does not assist allergan in determining the probable cause of these events.These events are being reported because medical intervention was required, although device-relatedness has not been established.

Event Description

Healthcare professional reported additionally that the patient developed a fever immediately post-implantation.The device was removed and discarded on (b)(6) 2015.Upon removal, the healthcare professional noted a seroma in the breast pocket.The healthcare professional concluded that the device had been physiologically rejected.

Manufacturer Narrative

The patient term codes for fever and seroma are submitted in addition to the previously reported patient codes, not in replacement.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.These events are being reported because medical intervention was required, although device-relatedness has not been established.

Manufacturer Narrative

The patient term code for inflammation is submitted in addition to the previously reported patient codes, not in replacement.These events are being reported because medical intervention was required, although device-relatedness has not been established.

Event Description

Healthcare professional reported additional information indicating the patient requires additional surgery to correct capsular contracture associated with her new breast implants, and residual inflammation that has been attributed to the seri device by the physician.

Manufacturer Narrative

The events of pain and capsular contracture are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for these events.

Event Description

Patient reported that seri surgical scaffold was placed bilaterally ¿under the base of each implant and base of [patient] chest wall¿ on (b)(6) 2014.After ¿a couple weeks,¿ the patient experienced ¿low-grade fevers¿ and ¿blotchy redness on the skin of [patient] right breast.¿ over the following two months, patient noted continuation of ¿low-grade fevers¿ as well as ¿marked changes in the appearance of both [patient] breasts¿ and ¿pain¿.Mammography showed ¿fluid buildup along the inferior aspect of both breast implants.¿ on (b)(6) 2015, the patient underwent bilateral explant of both breast implants and the concomitantly placed seri surgical scaffold.Explant was attributed to ¿severe inflammatory response¿ and ¿failure of the seri surgical scaffold resulting in bilateral capsular contracture.¿.

• 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: 4395875
• MDR Text Key: 5433023
• Report Number: 3008374097-2014-00145
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2016

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: 10/31/2016
• Device Catalogue Number: SCF10X25AGEN
• Device Lot Number: P13091001A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2013
• 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: IMPLANT AND SURGICAL SCAFFOLD.; PATIENT RECEIVED CONCOMITANT NON-ALLERGAN BREAST ; IMPLANT AND SURGICAL SCAFFOLD.; PATIENT RECEIVED CONCOMITANT NON-ALLERGAN BREAST
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female