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

Model Number M00514250

Device Problems Unraveled Material (1664); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and 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)(4) 2018, that an ultraflex esophageal proximal release covered stent was to be used to treat a malignant stricture in the esophagus during an esophageal stent placement procedure on (b)(6) 2018.Reportedly the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed inside the patient.Reportedly, the physician moved the stent up with forceps, and the proximal end of the stent was disconnected/unraveled.The stent was removed with forceps and the procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.Problem code 16645 captures the reportable event of stent unraveled.Problem code 3009 captures the reportable event of stent positioning issue.A deployed ultraflex esophageal covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found that the stent was unraveled.The stent was measured to be within specifications.No other issues were noted.The damage noted to the stent was likely due to manipulation of the device after deployment.The investigation concluded that most likely procedural factors, such as handling of the device, the techniques used by the user, and normal procedural difficulties encountered during the procedure may have limited the device performance.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018, that an ultraflex esophageal proximal release covered stent was to be used to treat a malignant stricture in the esophagus during an esophageal stent placement procedure on (b)(6) 2018.Reportedly the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was fully deployed inside the patient.Reportedly, the physician moved the stent up with forceps, and the proximal end of the stent was disconnected/ unraveled.The stent was removed with forceps and the procedure was completed with another ultraflex esophageal stent.There were no patient complications reported as a result of this event.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8200120
• MDR Text Key: 131520870
• Report Number: 3005099803-2018-62265
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR