MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565040
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex colonic stent was implanted to treat an intestinal obstruction in the colon during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during deployment, the stent was not in the proper location.The physician tried to reconstrain the stent but the stent could not be reconstrained.The physician then decided to release the stent and another wallflex colonic stent was placed 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 stable.
Additional Manufacturer Narrative
A deployed wallflex colonic stent delivery system was received for analysis, the stent was not returned.The distal end of the inner shaft was kinked.No other issues were noted with the stent holder or the remainder of the device during the product analysis.The noted damage to the delivery system was likely a result of the deployment attempt, as it was reported that the patient's anatomy was tight and was not dilated prior to stent placement.Taking all available information into consideration, the investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex colonic stent was implanted to treat an intestinal obstruction in the colon during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during deployment, the stent was not in the proper location.The physician tried to reconstrain the stent but the stent could not be reconstrained.The physician then decided to release the stent and another wallflex colonic stent was placed 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 stable.

• Brand Name: WALLFLEX¿ COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6676720
• Report Number: 3005099803-2017-01846
• Device Sequence Number: 16659124
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: (01)08714729456513(17)20190206(10)0020250707
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2019
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0020250707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 06/29/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR