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

Model Number M00516720

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aspiration/Inhalation (1725)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

(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 october 24, 2017 that a wallflex esophageal fully covered stent was to be used to treat a malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician placed the patient under complete sedation before introducing the stent delivery system.As the stent delivery system was being inserted into the esophagus, the patient coughed.The physician removed the delivery system from the patient but the contrast media was aspirated into the lungs.Reportedly, the physician took ¿emergency measures¿ to resolve the aspiration and plans to implant another stent.The patient¿s condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

A fully constrained wallflex esophageal fully covered stent and delivery system was received for analysis.The green braided polyester suture was inspected and no issues were observed.Visual examination of the returned device found the stent to be within specifications.Functional evaluation found it was possible to deploy the stent using the delivery system as received.No issues were noted to the stent and no other issues were noted to the device during the product analysis.A labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.Additionally, aspiration is indicated within the dfu as a potential adverse event.Taking all available information into consideration, the investigation concluded that the event is due to a known physiological effect of the procedure noted within the directions for use and/ or device labeling.Therefore, the most probable root cause assigned for this event is anticipated procedural complication.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered stent was to be used to treat a malignant esophageal stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician placed the patient under complete sedation before introducing the stent delivery system.As the stent delivery system was being inserted into the esophagus, the patient coughed.The physician removed the delivery system from the patient but the contrast media was aspirated into the lungs.Reportedly, the physician took ¿emergency measures¿ to resolve the aspiration and plans to implant another stent.The patient¿s condition at the conclusion of the procedure was reported to be stable.

• 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: 7034500
• MDR Text Key: 92151276
• Report Number: 3005099803-2017-03435
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: 08714729778059
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Type of Report: Initial,Followup
• Report Date: 10/24/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2018
• Device Model Number: M00516720
• Device Catalogue Number: 1672
• Device Lot Number: 20573816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2017
• 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 Age: 89 YR
• Patient Weight: 75