MAUDE Adverse Event Report: SEPRAFILM; MCN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aspiration/Inhalation (1725); Cardiopulmonary Arrest (1765); Death (1802); Asphyxia (1851); Pneumonia (2011); Vomiting (2144)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

Pneumonia [pneumonia]; aspiration [aspiration] ; asphyxia [asphyxia] ; cardio-respiratory arrest [cardio-respiratory arrest]; ileus [ileus]; vomiting [vomiting].Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article in the scope of post-marketing sponsored study: title: study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach.Authors: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.Journal: the 73rd annual meeting of the japan esophageal society.2019; unk: 135.Center id: unk; patient id: unknown; country: japan.Study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(4)(cluster).This case involves adult patient who experienced pneumonia, aspiration, asphyxia, cardio-respiratory arrest, ileus and vomiting, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, product for adhesion prevention seprafilm (number of sheets unknown) was used during laparotomy.On an unknown date, on the 9th day after the surgery, the patient experienced vomiting, aspiration, and asphyxia, which led to cardio-respiratory arrest; however, the patient was successfully resuscitated.On an unknown date, after 23 days, the patient died of pneumonia.Based on ct result, it was considered that, as small intestine was impacted in mediastinum, ileus occurred.On an unknown date, the patient died of pneumonia.It was unknown if autopsy was performed.Outcome of ileus, vomiting, cardio-respiratory arrest, asphyxia, and aspiration was unknown.The patient developed an event of a serious pneumonia.This event was assessed as medically significant and was leading to death.The patient developed an event of a serious aspiration.This event was assessed as medically significant.The patient developed an event of a serious asphyxia.This event was assessed as medically significant.The patient developed an event of a serious cardio-respiratory arrest.This event was assessed as medically significant.The patient developed an event of a serious ileus.This event was assessed as medically significant.The patient developed an event of a non-serious vomiting.Relevant laboratory test results included: computerised tomogram - on an unknown date: [based on ct result, it was considered that, as small intestine was impacted in mediastinum, ileus occurred.] final diagnosis was vomiting, ileus, cardio-respiratory arrest, asphyxia, aspiration and (fatal) pneumonia.It was not reported if the patient received a corrective treatment.The patient outcome is reported as fatal on an unknown date for pneumonia, as unknown for vomiting, as unknown for aspiration, as unknown for asphyxia, as unknown for cardio-respiratory arrest and as unknown for ileus.It is unknown if an autopsy was done.The cause of death was reported as pneumonia.Pneumonia is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Aspiration is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Asphyxia is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Cardio-respiratory arrest is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Ileus is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Vomiting is considered to be related to carboxymethylcellulose and sodium hyaluronate by the reporter and reportable by the company based on company causality assessment.Reporter comment: not reported.Amendment to the report dated 12-jun-2019: changed "does the incident represent a serious public threat?" from yes to no after clicked eu/ca device button.

Event Description

Pneumonia [pneumonia] aspiration [aspiration] asphyxia [asphyxia] cardio-respiratory arrest [cardio-respiratory arrest] ileus [ileus] vomiting [vomiting] case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.; study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach; the 73rd annual meeting of the japan esophageal society; 2019; unk: 135, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: japan study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(4).This case involves adult patient who experienced pneumonia, aspiration, asphyxia, cardio-respiratory arrest, ileus and vomiting, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, product for adhesion prevention seprafilm (number of sheets unknown) was used during laparotomy.On an unknown date, on the 9th day after the surgery, the patient experienced vomiting, aspiration, and asphyxia, which led to cardio-respiratory arrest; however, the patient was successfully resuscitated.On an unknown date, after 23 days, the patient died of pneumonia.Based on ct result, it was considered that, as small intestine was impacted in mediastinum, ileus occurred.On an unknown date, the patient died of pneumonia.It was unknown if autopsy was performed.Outcome of ileus, vomiting, cardio-respiratory arrest, asphyxia, and aspiration was unknown.The patient developed an event of a serious pneumonia.This event was assessed as medically significant and was leading to death.The patient developed an event of a serious aspiration.This event was assessed as medically significant.The patient developed an event of a serious asphyxia.This event was assessed as medically significant.The patient developed an event of a serious cardio-respiratory arrest.This event was assessed as medically significant.The patient developed an event of a serious ileus.This event was assessed as medically significant.The patient developed an event of a non-serious vomiting.Relevant laboratory test results included: computerised tomogram - on an unknown date: [based on ct result, it was considered that, as small intestine was impacted in mediastinum, ileus occurred.] final diagnosis was vomiting, ileus, cardio-respiratory arrest, asphyxia, aspiration and (fatal) pneumonia.It was not reported if the patient received a corrective treatment.The patient outcome is reported as fatal on an unknown date for pneumonia, as unknown for vomiting, as unknown for aspiration, as unknown for asphyxia, as unknown for cardio-respiratory arrest and as unknown for ileus.It is unknown if an autopsy was done.The cause of death was reported as pneumonia.Reporter causality between pneumonia and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Pneumonia is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between aspiration and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Aspiration is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between asphyxia and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Asphyxia is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between cardio-respiratory arrest and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Cardio-respiratory arrest is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between ileus and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Ileus is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between vomiting and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Vomiting is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter comment: the use of seprafilm reduces postoperative adhesive ileus; however, without aura, incidence of strangulation ileus due to abnormal hiatus that occurred during the surgery becomes high.Esophageal hiatus at the time of resection of the esophagus under laparotomy and impacted intestinal tract in hiatus area around diaphragm were the cause of strangulation ileus.The factor was that the attachment of seprafilm to area neighbor to the above lesion disturbed adhesion.Amendment to the report dated 12-jun-2019: changed "does the incident represent a serious public threat?" from yes to no after clicked eu/ca device button.Additional information was received on 28-jul-2019: no new information was received.Additional information was received on 25-jul-2019: no new information was received.Additional information was received on 25-jul-2019 (follow-up receipt date, 24-jul-2019; follow-up local pv receipt date, 25-jul-2019): added investigation summary from gqp quality operations, industrial affairs quality information management ((b)(4)).Added reporter's information and company comment.Correction to the previous report: corrected "causality as reported" and added reporter comment.

Event Description

Pneumonia, aspiration, asphyxia, cardio-respiratory arrest, ileus, and vomiting.Case narrative: initial information received on 12-jun-2019 regarding a solicited valid serious case issued from a literature article: miyachi m, saito t, watanabe y, asai y, kawai r, kawai t, et al.; study on merits and demerits of product for adhesion prevention seprafilm for subtotal excision of esophagus with laparotomy approach; the 73rd annual meeting of the japan esophageal society; 2019; unk: 135, in the scope of post-marketing sponsored study.Center id: unk; patient id: unk; country: japan.Study title: unsponsored study involving seprafilm.This case was issued in publication in which 5 other related cases were reported: (b)(6)(cluster).This case involves adult patient who experienced pneumonia, aspiration, asphyxia, cardio-respiratory arrest, ileus and vomiting, while he/she using with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, product for adhesion prevention seprafilm (number of sheets unknown) was used during laparotomy.On an unknown date, on the 9th day after the surgery, the patient experienced vomiting, aspiration, and asphyxia, which led to cardio-respiratory arrest; however, the patient was successfully resuscitated.On an unknown date, after 23 days, the patient died of pneumonia.Based on ct result, it was considered that, as small intestine was impacted in mediastinum, ileus occurred.On an unknown date, the patient died of pneumonia.It was unknown if autopsy was performed.Outcome of ileus, vomiting, cardio-respiratory arrest, asphyxia, and aspiration was unknown.The patient developed an event of a serious pneumonia.This event was assessed as medically significant and was leading to death.The patient developed an event of a serious aspiration.This event was assessed as medically significant.The patient developed an event of a serious asphyxia.This event was assessed as medically significant.The patient developed an event of a serious cardio-respiratory arrest.This event was assessed as medically significant.The patient developed an event of a serious ileus.This event was assessed as medically significant.The patient developed an event of a non-serious vomiting.Relevant laboratory test results included: computerised tomogram - on an unknown date: [based on ct result, it was considered that, as small intestine was impacted in mediastinum, ileus occurred.] final diagnosis was vomiting, ileus, cardio-respiratory arrest, asphyxia, aspiration and (fatal) pneumonia.It was not reported if the patient received a corrective treatment.The patient outcome is reported as fatal on an unknown date for pneumonia, as unknown for vomiting, as unknown for aspiration, as unknown for asphyxia, as unknown for cardio-respiratory arrest and as unknown for ileus.It is unknown if an autopsy was done.The cause of death was reported as pneumonia.Reporter causality between pneumonia and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Pneumonia is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between aspiration and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Aspiration is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between asphyxia and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Asphyxia is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between cardio-respiratory arrest and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Cardio-respiratory arrest is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between ileus and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Ileus is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter causality between vomiting and the drugs (carboxymethylcellulose and sodium hyaluronate) is not reported.Vomiting is considered to be reportable to carboxymethylcellulose and sodium hyaluronate by the company based on company causality assessment.Reporter comment: the use of seprafilm reduces postoperative adhesive ileus; however, without aura, incidence of strangulation ileus due to abnormal hiatus that occurred during the surgery becomes high.Esophageal hiatus at the time of resection of the esophagus under laparotomy and impacted intestinal tract in hiatus area around diaphragm were the cause of strangulation ileus.The factor was that the attachment of seprafilm to area neighbor to the above lesion disturbed adhesion.Amendment to the report dated 12-jun-2019: changed "does the incident represent a serious public threat?" from yes to no after clicked eu/ca device button.Additional information was received on 28-jun-2019: no new information was received.Additional information was received on 25-jul-2019: no new information was received.Additional information was received on 25-jul-2019 (follow-up receipt date, 24-jul-2019; follow-up local pv receipt date, 25-jul-2019) : added investigation summary from gqp quality operations, industrial affairs quality information management (investigation summary# (b)(4), event id: (b)(4)).Added reporter's information and company comment.Correction to the previous report: corrected "causality as reported" and added reporter comment.

• Brand Name: SEPRAFILM
• Type of Device: MCN
• MDR Report Key: 8722072
• MDR Text Key: 148802343
• Report Number: 1220423-2019-00016
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2019

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/01/2019; 08/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other