MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00555810

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

Patient Problem Pain (1994)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The complainant indicated that the device has been disposed 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 uncovered soft stent was implanted in the small intestine during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was a ¿tortuous area in a hairpin form and was an efferent loop¿.Placement was performed by retrograde approach and the flared end of the stent was on the anal side.In addition, there was inflammation, adhesion and hardening on the stent port side and on the flared part on the anal side.According to the complainant, the stent was successfully deployed.The physician noted that as a result of the inflammation, adhesion and hardening the flared end of the stent was positioned at the center of a curve and the stent got fixed due to inflammation and adhesion port side.Five hours post procedure, the patient experienced stomach ache, which prompted the physician to check the stent placement.It was noted through computerized tomography (ct) scan that the flared end of the stent had perforated the small intestine.Surgery was performed and the small intestine was partially resected.The perforation was resolved and the stent was removed during the surgical treatment.The patient¿s condition at the conclusion of the procedure was reported to be stable.The physician reportedly suspected, that since both the port side and anal sides of the stent were fixed due to inflammation and adhesion, the flared end of the stent linearized the middle of the curve it was in which caused the perforation.

• Brand Name: WALLFLEX¿ DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• 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: 6661845
• MDR Text Key: 78229015
• Report Number: 3005099803-2017-01903
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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
• 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 Model Number: M00555810
• Device Catalogue Number: 5581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2017
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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