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

Model Number	M00565110
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been implanted and is not available for return.If any further relevant information is received, a supplemental mdr 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 a recto-sigmoidal colonic stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to release the stent.However, only the distal part of the stent was noted to have expanded.The physician decided to keep the stent implanted and the patient is scheduled for a colostomy procedure.Reportedly, the patient has been hospitalized.
Additional Manufacturer Narrative
Additional information received from the complainant on january 05, 2018 and january 10, 2018.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex colonic stent was implanted to treat a recto-sigmoidal colonic stenosis during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to release the stent.However, only the distal part of the stent was noted to have expanded.The physician decided to keep the stent implanted and the patient is scheduled for a colostomy procedure.Reportedly, the patient has been hospitalized.Additional information received on january 5, 2018.It was further reported that the stent was implanted to treat a benign symmetric rigid ring circumferential stenosis in the right sigmoid region which was at 8-cm by digital palpation.The stent remains implanted and the patient was scheduled for a colostomy procedure in the same week after stent placement.Reportedly, the stent was not removed due to patient¿s tortuous anatomy.Additional information received on january 10, 2018.Medical notes were received that reported that the symmetric rigid ring circumferential recto-sigmoidal colonic stenosis was caused by probable extrinsic pelvic infiltrative injury.During the stent placement procedure, it was not possible to cross the stenosis with a colonoscope.A gastroscope was used instead, and the stenosis was examined.It was noted to be an exophytic, irregular friable lesion of infiltrative aspect.The wallflex colonic stent was advanced to the lesion and deployed.It was noted by direct vision endoscopy that the distal end of the stent expanded; however, when the stent was examined, a ¿collapse¿ was noticed in the middle third and the stent did not expand without continuity of the lumen.After evaluation in recovery, there were indications that the patient was feeding.

• Brand Name: WALLFLEX¿ COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7160464
• Report Number: 3005099803-2017-03893
• Device Sequence Number: 16495727
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: 08714729456582
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/11/2017

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: 12/19/2018
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0020094355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/26/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR