MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP; SURGICAL MESH

Catalog Number UNKAA066

Device Problems Defective Device (2588); Insufficient Information (3190)

Patient Problems Abscess (1690); Perforation (2001); Disability (2371)

Event Date 04/08/2017

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges intra-abdominal abscesses, infection, perforation, abdominal leak, adhesions, duodenal cutaneous fistula, abdominal distention, abdominal and pleuritic pain, nausea, vomiting, hospitalization, subsequent surgical intervention and severe and permanent injuries sustained by the patient; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.A review of the ifu performed finds it to be adequate.Review of the adverse reaction section of the ifu states that seroma, adhesions, hematomas, inflammation, extrusion, fistula formation and recurrence of the hernia are possible complications.¿in regards to the alleged infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis.¿ no medical records, autopsy, or death certificate have been provided.The fmea review identifies multiple potential adverse patient outcomes associated with surgery/use of the device including infection, perforation, adhesions, fistula.The review identifies controls in place to assess the failure modes and potential harms.Information provided by the patient's attorney is limited and review of the ifu and fmea does not assist in the identification of the root cause of the patient's alleged post-op complications.Should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

Attorney alleges that the plaintiff underwent surgery for the repair of 2 incisional hernias with non-bard/davol mesh and lysis of adhesions on (b)(6) 2015.Sometime after her surgery on (b)(6) 2015, the plaintiff began to experience the following symptoms: extreme fatigue, severe pain in the abdominal area, back pain, stomachaches, stomach gurgling, nausea and sharp pain with breathing (if active).The plaintiff was referred to a surgeon by her family physician for consult.The plaintiff saw the surgeon on (b)(6) 2017 for a consult, and was recommended to undergo hernia repair.The surgery was scheduled on elective basis.On (b)(6) 2017, the plaintiff was experiencing significant sharp abdominal pain and nausea.The pain had gotten worse over the three days.She underwent a ct-scan of her abdomen.The impression on the ct scan report states: "large midline epigastric hernia containing small bowel but without obstruction".She was discharged with tramacet medication for her pain.Prior to admission on (b)(6) 2017, in addition to her diabetic medications, the plaintiff was taking 2000mg ibuprofen and 500mg of vitamin c per day.The plaintiff was an in-patient from (b)(6) 2017 until (b)(6) 2017.On (b)(6) 2017, at approximately 0922, the plaintiff underwent lysis of adhesions and an open repair of incarcerated ventral hernia surgery.During the surgery, half of the old mesh was excised and sepramesh ip was placed.On (b)(6) 2017, the plaintiff developed abdominal distention, abdominal pain, nausea and significant shoulder and back pain, and pleuritic pain.On (b)(6) 2017, she was noted to be very unwell including symptoms of hypoxemia, tachycardia and she was unable to speak in full sentences.She was transferred to the icu.On (b)(6) 2017, at about 1806 hours, the plaintiff underwent further surgery for her persistent abdominal leak and enlarging fluid collections.During this procedure, the plaintiff underwent further lysis of adhesions for about 3 hours, drainage of multiple intra-abdominal abscesses and a graham patch repair of a large duodenal ulcer in the first part of the duodenum.The xcm biologic (non-bard) mesh was removed as part of the old mesh.On (b)(6) 2017, at about 0102 hours, the plaintiff underwent surgery for repair of her brachial and ulnar arteries on the right side after thrombosis due to injury to a brachial art line to right upper extremity ischemia.The surgeon felt her radial artery was occluded from previous multiple radial artery attempts.John doe or jane doe at a date unknown to the plaintiff negligently inserted the radial artery line causing injury to the plaintiff.On (b)(6) 2017, at about 1033 hours, the plaintiff underwent further surgery for repair or(f) the right brachial artery art line injury with a patch angioplasty with basilic vein, intraoperative angiogram.On (b)(6) 2017, an infectious disease specialist was consulted.This was the first consultation with an infectious disease specialist.After (b)(6) 2017, the plaintiff underwent several drainage procedures.On (b)(6) 2017, at about 1000 hours, the plaintiff underwent bedside percutaneous tracheostomy.As a result of the arterial line puncture, the plaintiff developed significant vascular damage and her right upper extremity developed dry gangrene to the index, long and ring fingertips.She also experiences significant pain.On (b)(6) 2017, the plaintiff underwent revised amputation of her right index.On (b)(6) 2017, the plaintiff was discharged.On (b)(6) 2017, the plaintiff returned to emergency at the same facility due to vomiting and foul smelling drainage from her abdomen.She returned on several occasions for ongoing complications related to her abdominal injuries and arterial injuries.On (b)(6) 2017, the patient underwent a gastroscopy for her duodenal cutaneous fistula.It is alleged that plaintiff sustained further injury, but not limited to perforation, infection, vascular injury, amputation and has to undergo numerous corrective surgeries and continues to experience symptoms.It is also alleged that the patient suffered a severe and permanent injury and the mesh was defective.

Event Description

Hold/db/6/28/23 attorney alleges that the plaintiff underwent surgery for the repair of 2 incisional hernias with non-bard/davol mesh and lysis of adhesions on (b)(6)-2015.Sometime after her surgery on (b)(6)-2015, the plaintiff began to experience the following symptoms: extreme fatigue, severe pain in the abdominal area, back pain, stomachaches, stomach gurgling, nausea and sharp pain with breathing (if active).The plaintiff was referred to a surgeon by her family physician for consult.The plaintiff saw the surgeon on (b)(6)-2017 for a consult, and was recommended to undergo hernia repair.The surgery was scheduled on elective basis.On (b)(6)-2017, the plaintiff was experiencing significant sharp abdominal pain and nausea.The pain had gotten worse over the three days.She underwent a ct-scan of her abdomen.The impression on the ct scan report states: "large midline epigastric hernia containing small bowel but without obstruction".She was discharged with tramacet medication for her pain.Prior to admission on (b)(6)-2017, in addition to her diabetic medications, the plaintiff was taking 2000mg ibuprofen and 500mg of vitamin c per day.The plaintiff was an in-patient from (b)(6)-2017 until (b)(6)-2017.On (b)(6)-2017, at approximately 0922, the plaintiff underwent lysis of adhesions and an open repair of incarcerated ventral hernia surgery.During the surgery, half of the old mesh was excised and sepramesh ip was placed.On (b)(6)-2017, the plaintiff developed abdominal distention, abdominal pain, nausea and significant shoulder and back pain, and pleuritic pain.On (b)(6)-2017, she was noted to be very unwell including symptoms of hypoxemia, tachycardia and she was unable to speak in full sentences.She was transferred to the icu.On (b)(6)-2017, at about 1806 hours, the plaintiff underwent further surgery for her persistent abdominal leak and enlarging fluid collections.During this procedure, the plaintiff underwent further lysis of adhesions for about 3 hours, drainage of multiple intra-abdominal abscesses and a graham patch repair of a large duodenal ulcer in the first part of the duodenum.The xcm biologic (non-bard) mesh was removed as part of the old mesh.On (b)(6)-2017, at about 0102 hours, the plaintiff underwent surgery for repair of her brachial and ulnar arteries on the right side after thrombosis due to injury to a brachial art line to right upper extremity ischemia.The surgeon felt her radial artery was occluded from previous multiple radial artery attempts.(b)(6)or (b)(6) at a date unknown to the plaintiff negligently inserted the radial artery line causing injury to the plaintiff.On (b)(6)-2017, at about 1033 hours, the plaintiff underwent further surgery for repair or(f) the right brachial artery art line injury with a patch angioplasty with basilic vein, intraoperative angiogram.On (b)(6)-2017, an infectious disease specialist was consulted.This was the first consultation with an infectious disease specialist.After (b)(6)-2017, the plaintiff underwent several drainage procedures.On (b)(6)-2017, at about 1000 hours, the plaintiff underwent bedside percutaneous tracheostomy.As a result of the arterial line puncture, the plaintiff developed significant vascular damage and her right upper extremity developed dry gangrene to the index, long and ring fingertips.She also experiences significant pain.On (b)(6)-2017, the plaintiff underwent revised amputation of her right index.On (b)(6)-2017, the plaintiff was discharged.On (b)(6)-2017, the plaintiff returned to emergency at the same facility due to vomiting and foul smelling drainage from her abdomen.She returned on several occasions for ongoing complications related to her abdominal injuries and arterial injuries.On (b)(6)-2017, the patient underwent a gastroscopy for her duodenal cutaneous fistula.It is alleged that plaintiff sustained further injury, but not limited to perforation, infection, vascular injury, amputation and has to undergo numerous corrective surgeries and continues to experience symptoms.It is also alleged that the patient suffered a severe and permanent injury and the mesh was defective.

Manufacturer Narrative

Device evaluation the zisv6 device of unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.Document review as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0118-5) lists arterial thrombosis as a known potential adverse event.There is no evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression 1.Stent fracture is confirmed.Type i fractures developed right inferior side of both 7mm stents between one and four years.The fractures were not associated with lumen stenosis or nih.2.Space between the stents and the artery wall consistent with peri-stent staining is confirmed.Although it may have developed after one year, it also may have just been uncovered by the 36-hour tpa infusion.Although commonplace in the past, infusions lasting more than one day are now usually unnecessary with more effective atherectomy/embolectomy devices.Peri-stent staining has been reported at 20 months post zilver ptx implantation (ann vasc dis.2018 sep 25; 11(3): 373¿376.).3.The 50% stenosis from nih in the superior most 6x80mm stent was insufficient to cause thrombosis.Root cause review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.From the information provided it is known that the patient underwent 36-hour drip tpa to treat thrombosis, a known potential adverse event within the ifu.Based on the clinical input received from this file it is known that the drip tpa was administered as a secondary intervention to treat thrombosis.It is likely that the drip tpa caused stent malapposition which in turn led to the blood flow behind the stents.In summary, a possible root cause could be attributed to stent malapposition as a result of the 36-hour drip tpa infusion administered to the patient to dissolve a blood clot.Summary complaint is confirmed as the failure was verified in the image(s).According to the initial reporter, the patient¿s outcome was noted to be stable/good.It is known that the entire stented segment was lined with a viabahn stent.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: SEPRAMESH IP
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10026868
• MDR Text Key: 189970602
• Report Number: 1213643-2020-04401
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability