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

Model Number M00516750

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The device has been received for analysis; however, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered stent was implanted to treat a stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017.According to the complainant, on (b)(6) 2017, an initial stent placement using a competitor device was attempted by a surgeon, however, the initial stent misdeployed into the stomach.A second physician was called to assist in the same case.The misdeployed stent was removed and a wallflex esophageal fully covered stent (the subject of this report) was implanted by the second physician.On (b)(6) 2017, the patient experienced dysphagia, which prompted the physician to check the stent through fluoroscopy.During fluoroscopy, the physician noted a waist on the stent, which was thought to be caused by a persistent stricture.However, when the physician checked the stent with the egd scope, the stent was noted to be moving freely and unable to maintain its position in the esophagus.The physician removed the stent using retrieval forceps; the explanted stent was found to have a green suture knotted around it causing a false waist.The stricture was deemed to be resolved and the procedure was completed with this device.In the physician¿s assessment, it is possible that the suture found knotted around the wallflex stent came from the misdeployed competitor stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be doing well.

Manufacturer Narrative

A wallflex esophageal fully covered stent was returned for analysis; the delivery system was not returned.Visual examination of the returned device found a foreign green suture with a small metallic piece wrapped around the midsection of the stent, which caused the stent¿s midsection to become narrow.After the foreign green suture was removed, the stent was measured to be within specifications.The green, braided wallflex stent retrieval suture was present and woven through proximal end of the stent per specifications; there were no issues with this suture.The stent covering was noted to be damaged near the knot of the stent¿s retrieval suture.No other issues were noted with the device.Device analysis determined that the condition of the returned device was consistent with the complaint incident.The wallflex esophageal stent uses a suture that is threaded during manufacturing process at the proximal end of the stent to aid in the removal in the initial placement and/or removal from benign strictures up to 8 weeks after the initial stent placement procedure, if necessary; however, this suture was found correctly woven in their suture holes per specifications.The investigation concluded that it is possible that the foreign green suture with the metallic piece found in the middle of the stent came from the non-bsc stent that was initially used during the procedure, which caused the reported events of stent failed/unable to expand, stent migration, and the observed damaged to the stent covering.Therefore, the most probable root cause for this complaint is "caused by other device." a labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered stent was implanted to treat a stricture in the esophagus during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2017.According to the complainant, on (b)(6) 2017, an initial stent placement using a competitor device was attempted by a surgeon, however, the initial stent misdeployed into the stomach.A second physician was called to assist in the same case.The misdeployed stent was removed and a wallflex esophageal fully covered stent (the subject of this report) was implanted by the second physician.On september 19, 2017, the patient experienced dysphagia, which prompted the physician to check the stent through fluoroscopy.During fluoroscopy, the physician noted a waist on the stent, which was thought to be caused by a persistent stricture.However, when the physician checked the stent with the egd scope, the stent was noted to be moving freely and unable to maintain its position in the esophagus.The physician removed the stent using retrieval forceps; the explanted stent was found to have a green suture knotted around it causing a false waist.The stricture was deemed to be resolved and the procedure was completed with this device.In the physician¿s assessment, it is possible that the suture found knotted around the wallflex stent came from the misdeployed competitor stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be doing well.

• 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: 6947919
• MDR Text Key: 89293429
• Report Number: 3005099803-2017-03099
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2017

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: M00516750
• Device Catalogue Number: 1675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention