MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516240

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 10/04/2019

Event Type  Death  

Manufacturer Narrative

(b)(6).(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on october 09, 2019 that a wallflex esophageal fully covered rmv stent has been implanted to prevent saliva leaking in to tissues around the left neck.The stent was implanted below the cricopharyngeus to seal a 2-3cm tracheo-oesophageal fistula during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient had previous surgeries, treatments and cancer, and the patient's carotid artery was compromised and weakened by previous radiation.According to the complainant, during the procedure, the stent functioned properly.However, the carotid artery was already weakened and placing the stent had caused stretching and pulling of the carotid artery.A massive bleed occurred.Reportedly, pressure was applied to treat the hemorrhage but the hemorrhage eventually led to the patient's death.In the physician's assessment, the stent was not at fault but may have contributed to the hemorrhage and the stent was associated with the patient's death.In addition, the physician reported that the previous surgeries, cancer and treatments were contributing factors to the hemorrhage and death.Note: according to the complainant, the wallflex esophageal fully covered rmv stent has been implanted to prevent saliva leaking in to tissues around the left neck.Reportedly, there was no concurrent esophageal malignant stricture.Per the wallflex esophageal fully covered rmv stent system directions for use (dfu), the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/ or extrinsic malignant tumors, occlusion of concurrent esophageal fistulas and treating refractory benign esophageal strictures.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9269605
• MDR Text Key: 164800011
• Report Number: 3005099803-2019-05111
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2019
• Device Model Number: M00516240
• Device Catalogue Number: 1624
• Device Lot Number: 0022161662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 55 YR