MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00569660
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: (b)(6) years.Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallstent rx biliary uncovered stent was used in the left hepatic duct to treat a jaundice due to malignant biliary stricture during a stent placement procedure performed on an unknown date.According to the complainant, during the procedure, the stent was difficult to deploy.However, the stent was able to be deployed but failed to completely open.Reportedly, a large portion of the stent was found inside the duodenum while the remaining part was in the hepatic duct due to its incomplete opening.The device was removed and another wallstent rx biliary uncovered stent was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation on july 24, 2019 that a wallstent rx biliary uncovered stent was used in the left hepatic duct to treat a jaundice due to malignant biliary stricture during a stent placement procedure performed on an unknown date.According to the complainant, during the procedure, the stent was difficult to deploy.However, the stent was able to be deployed but failed to completely open.Reportedly, a large portion of the stent was found inside the duodenum while the remaining part was in the hepatic duct due to its incomplete opening.The device was removed and another wallstent rx biliary uncovered stent was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on august 26, 2019*** according to the complainant, the stent placement procedure was an endoscopic retrograde cholangiopancreatography (ercp) procedure that may have occurred a few days before (b)(6) 2019.The stent was being placed in a stricture in the middle part of the common bile duct.The patient's anatomy was tortuous and was dilated prior to stent placement.Reportedly, the stent was removed with forceps a few hours after it was implanted.
Additional Manufacturer Narrative
Blocks b5 and e1 have been updated with additional information received on august 26, 2019.Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: problem code 3270 captures the reportable event of stent failed to expand.Problem code 3009 captures the reportable event of stent positioning issue.Conclusion code 4316 is being used in lieu of an adequate conclusion for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: problem code 3270 captures the reportable event of stent failed to expand.Problem code 3009 captures the reportable event of stent positioning issue.Block h10: a wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was received not deployed and was fully covered by the outer sheath.Visual examination of the returned device found that the stent wires perforated the exterior tube.There is evidence of reconstrainment/ attempted deployment as the distal tip was separated from the outer sheath at distal end.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received.No other issues with the stent and delivery system were noted.The reported event of stent failure to expand and stent positioning issue were not confirmed; the stent was received not deployed and was fully covered by the outer sheath.The wallstent biliary rx have cut ends by design and it is possible that the damage noted may have been a result during deployment/ reconstrainment attempts, where the wires may have got stuck causing the outer sheath perforation and therefore, inability to deploy the stent.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to some factors such as lesion characteristics and anatomical factors as the lesion was situated in the tight tortuous anatomy, handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2019 that a wallstent rx biliary uncovered stent was used in the left hepatic duct to treat a jaundice due to malignant biliary stricture during a stent placement procedure performed on an unknown date.According to the complainant, during the procedure, the stent was difficult to deploy.However, the stent was able to be deployed but failed to completely open.Reportedly, a large portion of the stent was found inside the duodenum while the remaining part was in the hepatic duct due to its incomplete opening.The device was removed and another wallstent rx biliary uncovered stent was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6), 2019*** according to the complainant, the stent placement procedure was an endoscopic retrograde cholangiopancreatography (ercp) procedure that may have occurred a few days before july 24, 2019.The stent was being placed in a stricture in the middle part of the common bile duct.The patient's anatomy was tortuous and was dilated prior to stent placement.Reportedly, the stent was removed with forceps a few hours after it was implanted.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8897692
• Report Number: 3005099803-2019-04083
• Device Sequence Number: 1617903
• Product Code: FGE
• UDI-Device Identifier: 08714729296867
• UDI-Public: 08714729296867
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K012752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2020

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 Model Number: M00569660
• Device Catalogue Number: 6966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 01/27/2020
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/20/2019; 02/18/2020
• 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: 32 YR