MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number M00553660

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Death (1802); Hemorrhage/Bleeding (1888)

Event Date 02/27/2019

Event Type  Death  

Manufacturer Narrative

Age or date of birth: patient's exact age is unknown; however it was reported that the patient was around (b)(6).Lot #, manufacture date: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.The complainant indicated that the device has been disposed of 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 mdr will be filed.

Event Description

It was reported to boston scientific on march 18, 2019 that a hot axios stent was successfully implanted in a transgastric position to treat a pancreatic cyst during a stent placement procedure performed on (b)(6) 2019.Endoscopic ultrasound (eus) doppler was performed on the cyst prior to stent placement.A double pigtail stent was placed through the axios stent to ensure that the back wall of the cyst did not collapse and embed into the stent.Necrosectomy was performed for two weeks following stent placement.Reportedly, the patient's pancreas was very scarred due to the cyst and necrosis.According to the complainant, on (b)(6) 2019, during a necrosectomy with axios removal procedure, the physician removed the stent using rat tooth forceps and noticed blood immediately following the stent as it was removed through the esophagus.Reportedly, the patient's cyst had resolved at the time of the stent removal procedure and eus doppler was not performed prior to the stent removal.In the physician's assessment, the bleeding may have been caused by the stent rubbing against the patient's friable tissue and eroding the splenic artery.The patient suffered a severe bleed and died.The complainant reported that there was no malfunction of the axios stent noted.

Event Description

It was reported to boston scientific on (b)(6) 2019 that a hot axios stent was successfully implanted in a transgastric position to treat a pancreatic cyst during a stent placement procedure performed on (b)(6) 2019.Endoscopic ultrasound (eus) doppler was performed on the cyst prior to stent placement.A double pigtail stent was placed through the axios stent to ensure that the back wall of the cyst did not collapse and embed into the stent.Necrosectomy was performed for two weeks following stent placement.Reportedly, the patient's pancreas was very scarred due to the cyst and necrosis.According to the complainant, on (b)(6) 2019, during a necrosectomy with axios removal procedure, the physician removed the stent using rat tooth forceps and noticed blood immediately following the stent as it was removed through the esophagus.Reportedly, the patient's cyst had resolved at the time of the stent removal procedure and eus doppler was not performed prior to the stent removal.In the physician's assessment, the bleeding may have been caused by the stent rubbing against the patient's friable tissue and eroding the splenic artery.The patient suffered a severe bleed and died.The complainant reported that there was no malfunction of the axios stent noted.Additional information received on 16apr2019: reportedly, the patient's cyst contained 60-70% necrotic material.Note: the stent was placed to treat a cyst with over 30% necrotic material; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts: 6cm in size and walled-off necrosis: 6cm in size with: 70% fluid content that are adherent to the gastric or bowel wall.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was around 70 years old.The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.The complainant indicated that the device has been disposed of 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 mdr will be filed.

• Brand Name: AXIOS
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8511367
• MDR Text Key: 141833685
• Report Number: 3005099803-2019-01690
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00553660
• Device Catalogue Number: 50270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death