MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESOPHAGEAL STENT WALLFLEX 23X10 M00516730; PROSTHESIS, ESOPHAGEAL

Model Number M00516730

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

Patient Problems Pain (1994); Cough (4457)

Event Date 12/15/2021

Event Type  Death  

Event Description

Patient is a (b)(6) yo a female with history of lung cancer (stage iiia squamous cell, right lung) diagnosed in (b)(6) of 2019.Patient was treated in 2019 with chemotherapy (paclitaxel + carboplatin) and radiation (due to not being a good surgery candidate) and completed initial therapy in (b)(6) 2019 and continued maintenance immunotherapy with durvalumab until (b)(6) 2021.Progression was observed in september of 2021 (via biopsy, squamous cell carcinoma) with growth into esophagus (positive for paratracheal lymph node).At this point, chemotherapy with gemcitabine was preferred due to patient not being a surgical candidate and chemotherapy was started in (b)(6)2021.Patient had esophageal stent placed on (b)(6) 2021 secondary to difficulty in swallowing but has pain and coughing post stent placement.Multiple providers have noted that patient's advanced lung cancer that eroded into patient's esophagus.Additionally, patient declined esophagogastroduodenoscopy to confirm extend of cancer growth into esophagus.Patient admitted to ed on (b)(6) 2021 with hemoptysis and coughing up copious amounts of dark red blood.Patient expired on (b)(6) 2021 via hospice care.Medwatch report being completed secondary to device (stent) and pain/hemoptysis events.Fda safety report id# (b)(4).

Event Description

Patient is a (b)(6) yo a female with history of lung cancer (stage iiia squamous cell, right lung) diagnosed in (b)(6) of 2019.Patient was treated in 2019 with chemotherapy (paclitaxel + carboplatin) and radiation (due to not being a good surgery candidate) and completed initial therapy in (b)(6) 2019 and continued maintenance immunotherapy with durvalumab until (b)(6) 2021.Progression was observed in (b)(6) of 2021 (via biopsy, squamous cell carcinoma) with growth into esophagus (positive for paratracheal lymph node).At this point, chemotherapy with gemcitabine was preferred due to patient not being a surgical candidate and chemotherapy was started in (b)(6) 2021.Patient had esophageal stent placed on (b)(6) 2021 secondary to difficulty in swallowing but has pain and coughing post stent placement.Multiple providers have noted that patient's advanced lung cancer that eroded into patient's esophagus.Additionally, patient declined esophagogastroduodenoscopy to confirm extend of cancer growth into esophagus.Patient admitted to ed on (b)(6) 2021 with hemoptysis and coughing up copious amounts of dark red blood.Patient expired on (b)(6) 2021 via hospice care.Medwatch report being completed secondary to device (stent) and pain/hemoptysis events.Fda safety report id# (b)(4).

• Brand Name: ESOPHAGEAL STENT WALLFLEX 23X10 M00516730
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 13514214
• MDR Text Key: 285538350
• Report Number: MW5107384
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00516730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White