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

Model Number M00516260

Device Problems Use of Device Problem (1670); Activation Failure (3270)

Patient Problems Fever (1858); Pain (1994); No Code Available (3191)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

Patient's weight: (b)(6).(b)(4).The complainant indicated that the device was disposed and 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 medwatch will be filed.

Event Description

Note: refer to manufacturer report # 3005099803-2019-03512 for the associated device information.It was reported to boston scientific corporation on june 26, 2019 that two wallflex esophageal fully covered rmv stents had been implanted to treat an esophageal leakage during a stent placement procedure.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.Reportedly, there was no concurrent malignancy at the intended placement site.According to the complainant, on (b)(6) 2019, the first wallflex esophageal stent (the subject of mfr.Report # 3005099803-2019-03512) was successfully deployed; however, on (b)(6) 2019, the patient presented with pain and fever.The physician checked the stent and confirmed that the stent was collapsed, shrunken and was not expanded.Reportedly, the physician tried to expand the stent using a balloon catheter but this was not successful.The stent was removed with forceps and another wallflex esophageal stent (the subject of this report) was used to complete the procedure.On (b)(6) 2019, the same thing occurred.The stent was removed with forceps and no new stent was implanted.No additional treatment or intervention was provided to resolve the leakage.The leakage was treated with conservative management during a one month stay in the hospital.The patient was discharged and the patient's current condition was reported to be excellent.Note: according to the complainant, the wallflex esophageal fully covered stent was placed to treat esophageal leakage without a concurrent malignancy.However, per wallflex esophageal fully covered stent system directions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8807837
• MDR Text Key: 151606054
• Report Number: 3005099803-2019-03513
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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: 07/19/2019

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: 08/26/2020
• Device Model Number: M00516260
• Device Catalogue Number: 1626
• Device Lot Number: 0023400733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 36 YR