MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565010

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported event of stent partially deployed.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)(4) 2016 that a wallflex enteral duodenal stent was to be used to treat a pyloric stenosis due to gastric cancer during a stent placement procedure with guided fluoroscopy performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was not tortuous.According to the complainant, during the procedure, the physician was able to deploy 4 cm of the stent when the stent could no longer be deployed.The physician was unable to reconstrain the stent and removed the partially deployed stent from the patient.The procedure was completed with a different device.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 have ¿no problem¿.

Manufacturer Narrative

Investigation results a wallflex ¿ duodenal stent and delivery system was returned for analysis.The stent was partially deployed.Visual evaluation found buckling of the outer sheath and slight bending of the stainless steel tube.Functional evaluation found the stent was possible to fully reconstrain and then deploy.No other issues were noted with the device.The investigation noted that the observed damage to the device is consistent with the application of excessive force during usage.Therefore, the cause of the reported deployment difficulties and noted device defects was most probably due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for this complaint is operational context.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral duodenal stent was to be used to treat a pyloric stenosis due to gastric cancer during a stent placement procedure with guided fluoroscopy performed on (b)(6) 2016.Reportedly, the patient¿s anatomy was not tortuous.According to the complainant, during the procedure, the physician was able to deploy 4 cm of the stent when the stent could no longer be deployed.The physician was unable to reconstrain the stent and removed the partially deployed stent from the patient.The procedure was completed with a different device.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 have ¿no problem¿.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 6121916
• MDR Text Key: 60760794
• Report Number: 3005099803-2016-03604
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: K062750
• 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: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2018
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 19489045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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