MAUDE Adverse Event Report: SOFRADIM PRODUCTION PERMACOL 5X5 1MM; MESH, SURGICAL

Model Number 5000-100

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Http://rd.Springer.Com/article/10.1007/s10029-015-1390-5.

Event Description

A detailed retrospective analysis of all patients who underwent biologic mesh reinforced cruroplasty in the repair of large and complex para-esophageal hernia was performed utilizing the prospectively maintained esophago-gastric database at the (b)(6) between (b)(6) 2004 and (b)(6) 2013.During the study period, the department performed 132 para-esophageal hernia repair operations, of which 51 (39%) procedures were carried out in 49 patients utilizing mesh as described above.All procedures were attempted laparoscopically, and completed successful repair was achieved in 50 cases (98%).The indications for surgery were large primary type iii/iv para-esophageal hernia (41/51, 80%); recurrent peh (6/51, 12%), 2 of whom had previously had mesh reinforced cruroplasty; crural herniation following previous anti-reflux surgery (4/ 51, 8%).Criteria for consideration of mesh placement was width [4 cm in 42 (83%), divergent crural angle 37 (73%) and poor quality crura in 22 (43%).Both patients with recurrent herniation were mesh-reinforced.Two patients had symptoms of dysphagia related to the mesh: 1 in the postoperative period and 1 at routine follow-up.The patient with early post-operative dysphagia had undergone a 360-degrees fundoplication with a 5 cm x 5 cm x 1 mm mesh.The patient with late-onset dysphagia also had a 360-degrees fundoplication and 5 cm x 5 cm x 1 mm mesh.Successful resolution of symptoms was achievable in all cases with endoscopic balloon dilatation.

Manufacturer Narrative

(b)(4).

Event Description

Additional information has been requested but not yet received.

• Brand Name: PERMACOL 5X5 1MM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5615194
• MDR Text Key: 43898419
• Report Number: 9615742-2016-00022
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

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 Model Number: 5000-100
• Device Catalogue Number: 5000-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/28/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention