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

Model Number M00516950

Device Problem Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was fully deployed and got bent into the tumor.In the physician's assessment the patient's tortuous anatomy contributed to the deformed stent inside the tumor.The stent was removed from the patient with forceps; however, as the stent was removed it grazed the esophagus which resulted in bleeding.The procedure was completed with another wallflex esophageal stent, which was also used as tamponade for the bleed, and no other intervention was performed to address the bleeding.The patient's condition at the conclusion of the procedure was reported to be good.

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 problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0406 captures the reportable event of stent material deformation.Block h10: a fully deployed and expanded wallflex esophageal stent was received for analysis; the delivery system was not returned.The stent was inspected and no damages were noted.The reported event of stent material deformation was not confirmed as the stent was received fully deployed and expanded.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, bleeding (hemorrhage, minor) is noted within the ifu as a potential adverse event associated with the use of this device.It is most likely that the characteristics of the lesion and the patient's tortuous anatomy limited the performance of the device and contributed to the damaged stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.A ship history was unable to be performed as customer number was not available.

Event Description

It was reported to boston scientific corporation on (b)(6), 2022 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6), 2022.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was fully deployed and got bent into the tumor.In the physician's assessment the patient's tortuous anatomy contributed to the deformed stent inside the tumor.The stent was removed from the patient with forceps; however, as the stent was removed it grazed the esophagus which resulted in bleeding.The procedure was completed with another wallflex esophageal stent, which was also used as tamponade for the bleed, and no other intervention was performed to address the bleeding.The patient's condition at the conclusion of the procedure was reported to be good.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14174920
• MDR Text Key: 289896917
• Report Number: 3005099803-2022-02108
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: 08714729765295
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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: M00516950
• Device Catalogue Number: 1695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/02/2022
• 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
• Patient Sex: Female