MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPACEOAR VUE SYSTEM; ABSORBABLE PERIRECTAL SPACER

Model Number SV-2101

Device Problems Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Inflammation (1932); Ischemia (1942); Nausea (1970); Necrosis (1971); Pain (1994); Vomiting (2144); Discomfort (2330); Syncope/Fainting (4411); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device remains implanted 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 corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021.After the procedure the post operation imaging showed the spaceoar gel in the correct location it was unclear from the imaging if the full 10 ccs were placed.The patient experienced pelvic pain and discomfort during and after the procedure.Before the patient went home the pain and discomfort got a little bit better.The patient had a vagal/diaphoretic event before leaving the hospital.The patient reported that his pain later that day was the worst he has experienced in his life.He continued to have the pain the next day, (b)(6) 2021.On (b)(6) 2021 the patient went to the emergency department.The computed tomography (ct) imaging showed the spaceoar vue slightly shifted to the right but apparently no obvious rectal wall invasion.The patient was taken to the operating room, where he was found to have obstruction of the ima (inferior mesenteric artery) causing bowel necrosis requiring an emergency colon resection from the splenic flexure to the rectum and colostomy.The patient was hospitalized with a colostomy.

Event Description

It was reported to boston scientific corporation that spaceoar vue was implanted during a spaceoar vue placement procedure performed on (b)(6) 2021.After the procedure the post operation imaging showed the spaceoar gel in the correct location it was unclear from the imaging if the full 10 ccs were placed.The patient experienced pelvic pain and discomfort during and after the procedure.Before the patient went home the pain and discomfort got a little bit better.The patient had a vagal/diaphoretic event before leaving the hospital.The patient reported that his pain later that day was the worst he has experienced in his life.He continued to have the pain the next day, (b)(6) 2021.On friday, (b)(6) 2021 the patient went to the emergency department.The computed tomography (ct) imaging showed the spaceoar vue slightly shifted to the right but apparently no obvious rectal wall invasion.The patient was taken to the operating room, where he was found to have obstruction of the ima (inferior mesenteric artery) causing bowel necrosis requiring an emergency colon resection from the splenic flexure to the rectum and colostomy.The patient was hospitalized with a colostomy.On june 28, 2021, additional information received via pathology report, stating that the patient developed abdominal pain, fever, nausea and vomiting and presented to the emergency room after the spaceoar procedure.The patient was placed on nasogastric tube (ng tube) for ileus and iv antibiotics.He underwent an exploratory laparotomy on following failure of symptom resolution at which time the descending colon, sigmoid colon and proximal rectum were noted to be necrotic.According to the pathology report, "the colon and rectum demonstrate diffuse transmural ischemic necrosis with evidence of pericolorectal acute and chronic inflammation and serositis.The submucosal and pericolorectal vasculature demonstrates extensive organizing venous fibrin thrombi and muscular arteries to appear to demonstrate intraluminal basophilic foreign material which was not polarizable.The basophilic material was present both within small and larger vessels with some foci demonstrating and adjacent foreign body giant cell reaction.These vascular changes appear to be confined to areas of ischemic mucosal injury and are absent in areas of viable tissue.Similar basophilic material was not seen in the surrounding tissue.".It was reported that, the basophilic material was difficult to characterized with certainty, it demonstrates similar but not identical histologic features to what has been reported with ischemic events secondary to hydrophilic polymers.Given the relationship to the patient's spaceoar hydrogel placement, one posibility is that some of the hydrogel may have inadvertently been injected intravascular.

Manufacturer Narrative

Additional infromation received on june 28, 2021 and correction was made on the following field.Block b5:describe event or problem block h6: patient codes updated, impact codes updated.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.Block h6: clinical code e2330 captures the reportable event of pain patient code e2402 was use to capture the reportable event of additional intervention required.Block h10: the complainant indicated that the device remains implanted 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: SPACEOAR VUE SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12037607
• MDR Text Key: 257756049
• Report Number: 3005099803-2021-02973
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• PMA/PMN Number: K182971
• 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: 07/23/2021

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
• Device Operator: Health Professional
• Device Model Number: SV-2101
• Device Catalogue Number: SV-2101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention