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

Model Number M00516600

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).E7025 wallflex esophageal fully covered benign anastomotic stricture rct clinical trial.The device has not been received for analysis; 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

It was reported to boston scientific corporation that a wallflex esophageal stent was implanted to treat a 0.3cm anastomotic stricture in the esophagus during a stent placement procedure performed on (b)(6), 2015 as part of the e7025 wallflex esophageal fully covered benign anastomotic stricture rct clinical study.The patient had undergone a trans-thoracic esophagectomy on (b)(6), 2014.The anastomosis was combined (hand sewn and stapled).The patient had a fistula formation post esophagectomy.The post esophagectomy anastomotic stricture was originally diagnosed on (b)(6), 2014.On (b)(6), 2014, the first post esophagectomy dilation was performed and the second dilation was performed on (b)(6), 2014.The maximum diameter of the last dilation was 16mm.The patient's baseline visual analog score (vas) pain scale score was recorded as 0.On (b)(6), 2015, the patient's baseline dysphagia score was "2-ability to swallow semisolid foods".According to the complainant, during the stent placement procedure on (b)(6), 2015 the wallflex esophageal stent was successfully implanted and remained in place at the end of the procedure.The proximal edge of the stent was placed 18cm from the incisors.The proximal edge of the anastomotic stricture was located 21cm from the incisors.This procedure was completed as an outpatient procedure.On (b)(6), 2015, the patient underwent the per-protocol stent removal procedure.At this time, it was noted that the wallflex esophageal stent had a complete distal migration.The stent was successfully removed from the patient's stomach.The clinical site deemed the event a device deficiency.The migration was determined to be a result of stricture resolution.There were no adverse events associated with this event.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5128456
• MDR Text Key: 27501834
• Report Number: 3005099803-2015-02865
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2015
• Device Model Number: M00516600
• Device Lot Number: 16866414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• 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 Age: 67 YR