BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE
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Model Number M00555780 |
Device Problems
Material Integrity Problem (2978); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-02898 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2022 that two wallflex colonic soft stent system with anchor lock delivery systems were implanted to treat a malignant colonic stricture in the sigmoid colon and as a bridge to surgery during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, the first wallflex colonic soft stent (the subject of mfr.Report# 3005099803-2022-02898) was able to be deployed but after stent deployment, the stent was not visible under endoscopic view.The physician suspected a stent malfunction and decided to remove the delivery system.A second wallflex colonic soft stent (the subject of this report) was deployed; but the same problem occurred, the second stent was not visible under endoscopic view.However, when the physician checked under fluoroscopy, it was noted that two wallflex colonic soft stents were implanted in an incorrect position.The stents remain implanted and the procedure was stopped as the patient was sent to emergency surgery for a colostomy and colon resection.The patient's condition following the procedure is reported to be stable.
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Manufacturer Narrative
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Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Impact code f19 captures the surgical intervention of colostomy and colon resection to treat the patient.Block h10: the complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: correction to the initial mdr in block h6 (device codes).
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-02898 for the associated device information.It was reported to boston scientific corporation on may 10, 2022 that two wallflex colonic soft stent system with anchor lock delivery systems were implanted to treat a malignant colonic stricture in the sigmoid colon and as a bridge to surgery during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, the first wallflex colonic soft stent (the subject of mfr.Report# 3005099803-2022-02898) was able to be deployed but after stent deployment, the stent was not visible under endoscopic view.The physician suspected a stent malfunction and decided to remove the delivery system.A second wallflex colonic soft stent (the subject of this report) was deployed; but the same problem occurred, the second stent was not visible under endoscopic view.However, when the physician checked under fluoroscopy, it was noted that two wallflex colonic soft stents were implanted in an incorrect position.The stents remain implanted and the procedure was stopped as the patient was sent to emergency surgery for a colostomy and colon resection.The patient's condition following the procedure is reported to be stable.
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Manufacturer Narrative
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Blocks b5 and d6b have been updated with additional information received on august 04, 2022.Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Impact code f19 captures the surgical intervention of colostomy and colon resection to treat the patient.Block h10: a wallflex colonic soft uncovered stent was received for analysis; the delivery system was not returned.The stent was received fully deployed.No issues were noted to the stent during visual inspection.Product analysis could not confirm the reported event of stent positioning issue; the reported event occurred during the procedure and could not be functionally/visually verified.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, stent misplacement or inadequate expansion is noted within the dfu as a potential complications associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Event Description
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Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-02898 for the associated device information.It was reported to boston scientific corporation on may 10, 2022 that two wallflex colonic soft stent system with anchor lock delivery systems were implanted to treat a malignant colonic stricture in the sigmoid colon and as a bridge to surgery during a stent placement procedure performed on may 10, 2022.Reportedly, the patient's anatomy was tortuous.During the procedure, the first wallflex colonic soft stent (the subject of mfr.Report# 3005099803-2022-02898) was able to be deployed but after stent deployment, the stent was not visible under endoscopic view.The physician suspected a stent malfunction and decided to remove the delivery system.A second wallflex colonic soft stent (the subject of this report) was deployed; but the same problem occurred, the second stent was not visible under endoscopic view.However, when the physician checked under fluoroscopy, it was noted that two wallflex colonic soft stents were implanted in an incorrect position.The stents remain implanted and the procedure was stopped as the patient was sent to emergency surgery for a colostomy and colon resection.The patient's condition following the procedure is reported to be stable.Additional information received on august 04, 2022.The two wallflex colonic soft stent system with anchor lock delivery systems were deployed in an incorrect location and were removed during a surgical procedure performed on (b)(6) 2022.
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Search Alerts/Recalls
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