MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number UNK477

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Death (1802)

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the upn and the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device is implanted 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex¿ esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure.Reportedly, the wallflex¿ esophageal stent was placed for an anastomotic stricture/leak post gastric surgery as part of palliative treatment for esophageal cancer.According to the complainant, the patient expired post procedure.The relationship between the patient¿s death and the stent was not reported.However, it was noted that the stent was in good standing on expiration and there was no alleged malfunction with the stent.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.Note: according to the complainant, the wallflex esophageal fully covered stent was placed for an anastomotic stricture/leak post gastric surgery.However, per the wallflex esophageal fully covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Manufacturer Narrative

Per the complainant, the patient initially presented to an emergency room in (b)(6) and was transferred to (b)(6).(b)(4).(outcomes attrib.To ae) and have been updated based on corrected information received on march 26, 2018.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex¿ esophageal stent was implanted in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure.Reportedly, the wallflex¿ esophageal stent was placed for an anastomotic stricture/leak post gastric surgery as part of palliative treatment for esophageal cancer.According to the complainant, the patient expired post procedure.The relationship between the patient¿s death and the stent was not reported.However, it was noted that the stent was in good standing on expiration and there was no alleged malfunction with the stent.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.Note: according to the complainant, the wallflex esophageal fully covered stent was placed for an anastomotic stricture/leak post gastric surgery.However, per the wallflex esophageal fully covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.Additional information received on march 26, 2018.The stent was placed at an anastomotic site between the esophagus and stomach for an anastomotic leak.The anastomotic leak was due to a previous gastric resection surgery.According to the complainant, post stent placement, the stent eroded through the anastomotic opening and migrated into patients aorta.The patient presented to the emergency room at one hospital and was transferred to a different hospital.The stent was removed and the patient was stabilized and survived.The patient did not expire.As of (b)(6) 2018, the patient was reported to be hospitalized and in stable condition.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7342296
• MDR Text Key: 102510478
• Report Number: 3005099803-2018-00792
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

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 Model Number: UNK477
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention