MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00513850
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent cover 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 or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng proximal release covered stent was implanted to treat a malignant stricture in the distal esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, 50 days post stent placement, the patient experienced dysphagia.During a gastroscopy procedure, the physician noted that the stent cover was partially detached from the stent.The detached cover was removed with a biopsy forceps.Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in place.The patient condition following the procedure was reported to be stable.The patient's dysphagia was noted to have resolved.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal ng proximal release covered stent was implanted to treat a malignant stricture in the distal esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, 50 days post stent placement, the patient experienced dysphagia.During a gastroscopy procedure, the physician noted that the stent cover was partially detached from the stent.The detached cover was removed with a biopsy forceps.Reportedly, the stent remains implanted and the physician was comfortable leaving the stent in place.The patient condition following the procedure was reported to be stable.The patient's dysphagia was noted to have resolved.
Additional Manufacturer Narrative
(b)(4).An ultraflex esophageal stent cover was returned for analysis; the stent and delivery system were not returned.Visual analysis of the returned device found that the stent cover was damaged (broken).Device analysis determined that the condition of the returned device was consistent with the reported event that the stent cover migrated.The noted damage to the stent cover is consistent with force being applied during removal of the cover using biopsy forceps.Peristaltic waves in the esophagus, stomach and intestines could have caused the stent cover to migrate.Therefore, the investigation concluded that the most probable root cause is caused traced to component failure, as there was an expected or random component failure without any design or manufacturing issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7965757
• Report Number: 3005099803-2018-60702
• Device Sequence Number: 19220423
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 05/20/2020
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0022146217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 12/03/2018
• 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: Required Intervention