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

Model Number M00565010

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex ¿ duodenal stent was implanted to treat a 3 to 4 cm malignant lesion in the duodenum during a stent placement procedure performed on (b)(6) 2017.Reportedly, the lesion was not dilated prior to stent placement.According to the complainant, the physician was able to deploy the stent.However,during the removal of the delivery system, it got caught up at the distal end of the stent, thus, making it difficult to remove the delivery system.The stent was moved out of position when the physician withdraw the delivery system.The stent remains implanted and the physician placed another wallflex duodenal stent (stent-in-stent) to cover the entire lesion to complete the procedure.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 fine.

• 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: 6657767
• MDR Text Key: 78092845
• Report Number: 3005099803-2017-01854
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: (01)08714729456483(17)20190421(10)20550362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• 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
• Report Date: 05/31/2017

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 Expiration Date: 04/21/2019
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 20550362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2017
• 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