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

Model Number SV-2101

Device Problem Positioning Problem (3009)

Patient Problems Adhesion(s) (1695); Pain (1994); Numbness (2415); Diminished Pulse Pressure (2606); Embolism/Embolus (4438)

Event Date 04/06/2021

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.Gold fiducials were administered prior to spaceoar implantation and the procedure was done under general anesthesia.The patient anatomy was atypical, there was very little peri-prostatic fat and the prostate was very small.When the saline was injected, most of it was dissecting to the left, so they moved the needle a little to the right.After the procedure, prior to discharge, the patient developed pain and numbness in his right leg and his dorsalis pedis pulse was weak.The patient also had adhesions and was losing blood flow in right leg, indicating an arterial problem.The patient was put on heparin and his symptoms improved by 80%, some numbness was still present.Computed tomography angiography (cta) was performed and it showed good flow to the extremities.On the right side, they found material they believed to be spaceoar vue gel, in the junction of the common iliac artery, shifting into the internal iliac artery.According to the physician, they believed they sheared an artery and injected the gel under high pressure and that pressure pushed the gel up the flow of blood into the common iliac artery.They placed an arterial balloon stent to push the material outside the blood flow.The patient was reported to have recovered and he will continue on blood thinners.External beam radiation therapy (ebrt) will proceed as planned.

Manufacturer Narrative

Additional information received on may 10, 2021.Block b5: incident narrative.Block h6: patient code e2101 adhesion(s) removed.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 e0609 captures the reportable event of diminished pulse pressure.Clinical code e0127 captures the reportable event of numbness.Medical device problem code a1502 captures the reportable event of gel misplaced, vascular.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.

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.Fiducials were administered prior to spaceoar implantation and the procedure was done under general anesthesia.The patient anatomy was atypical, there was very little peri-prostatic fat and the prostate was very small.When the saline was injected, most of it was dissecting to the left, so they moved the needle a little to the right.After the procedure prior to discharge, the patient developed pain and numbness in his right leg and his dorsalis pedis pulse was weak.The patient also had adhesions and was losing blood flow in right leg, indicating an arterial problem.The patient was put on heparin and his symptoms improved by 80%, some numbness was still present.Computed tomography angiography (cta) was performed and it showed good flow to the extremities.On the right side, they found material they believed to be spaceoar, in the junction of the common iliac artery, shifting into the internal iliac artery.According to the physician, they believed they sheared an artery and injected the gel under high pressure and that pressure pushed the gel up the flow of blood into the common iliac artery.They placed an arterial balloon stent to push the material outside the blood flow.The patient was reported to have recovered and he will continue on blood thinners.External beam radiation therapy (ebrt) will proceed as planned.Additional information received on may 10, 2021, states that the reported event of adhesion, is referring to the spaceoar adhering to the side of the iliac artery, causing the numbness in the patient's right leg.

Manufacturer Narrative

Additional information received on july 16, 2021.Block h6: patient code e0503 embolism was added.Additional information received on may 10, 2021.Block b5: incident narrative.Block h6: patient code e2101 adhesion(s) removed.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 e0609 captures the reportable event of diminished pulse pressure.Clinical code e0127 captures the reportable event of numbness.Medical device problem code a1502 captures the reportable event of gel misplaced, vascular.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.

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.Fiducials were administered prior to spaceoar implantation and the procedure was done under general anesthesia.The patient anatomy was atypical, there was very little peri-prostatic fat and the prostate was very small.When the saline was injected, most of it was dissecting to the left, so they moved the needle a little to the right.After the procedure prior to discharge, the patient developed pain and numbness in his right leg and his dorsalis pedis pulse was weak.The patient also had adhesions.And was losing blood flow in right leg, indicating an arterial problem.The patient was put on heparin and his symptoms improved by 80%, some numbness was still present.Computed tomography angiography (cta) was performed and it showed good flow to the extremities.On the right side, they found material they believed to be spaceoar, in the junction of the common iliac artery, shifting into the internal iliac artery.According to the physician, they believed they sheared an artery and injected the gel under high pressure and that pressure pushed the gel up the flow of blood into the common iliac artery.They placed an arterial balloon stent to push the material outside the blood flow.The patient was reported to have recovered and he will continue on blood thinners.External beam radiation therapy (ebrt) will proceed as planned.Additional information received on may 10, 2021, states that the reported event of adhesion, is referring to the spaceoar adhering to the side of the iliac artery, causing the numbness in the patient's right leg.

Manufacturer Narrative

Additional information received on july 16, 2021.Block h6: patient code e0503 embolism was added.Additional information received on may 10, 2021 block b5: incident narrative.Block h6: patient code e2101 adhesion(s) removed.Additional information received on december 27, 2022.Block a2: patient's age corrected.Block b2: outcomes attrib to adv event.Block b5: incident narrative.Block b6: relevant tests/laboratory data check.Block b7: other relevant history.Block g2: literature was added.Block h6: impact codes.Block g2: literature source: qiao y, et al, (2022) a case report: retrograde arterial embolization of locally-injected spaceoar hydrogel material into the right common iliac artery bifurcation.Radiology case reports 18 (2023), 719-726.Https://doi.Org/10.1016/j.Radcr.2022.02.042 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 e0609 captures the reportable event of diminished pulse pressure.Clinical code e0127 captures the reportable event of numbness.Medical device problem code a1502 captures the reportable event of gel misplaced, vascular.

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.Fiducials were administered prior to spaceoar implantation and the procedure was done under general anesthesia.The patient anatomy was atypical, there was very little peri-prostatic fat and the prostate was very small.When the saline was injected, most of it was dissecting to the left, so they moved the needle a little to the right.After the procedure prior to discharge, the patient developed pain and numbness in his right leg and his dorsalis pedis pulse was weak.The patient also had adhesions and was losing blood flow in right leg, indicating an arterial problem.The patient was put on heparin and his symptoms improved by 80%, some numbness was still present.Computed tomography angiography (cta) was performed and it showed good flow to the extremities.On the right side, they found material they believed to be spaceoar, in the junction of the common iliac artery, shifting into the internal iliac artery.According to the physician, they believed they sheared an artery and injected the gel under high pressure and that pressure pushed the gel up the flow of blood into the common iliac artery.They placed an arterial balloon stent to push the material outside the blood flow.The patient was reported to have recovered and he will continue on blood thinners.External beam radiation therapy (ebrt) will proceed as planned.Additional information received on may 10, 2021, states that the reported event of adhesion, is referring to the spaceoar adhering to the side of the iliac artery, causing the numbness in the patient's right leg.Additional information received on december 27, 2022.Boston scientific corporation became aware of the following event from referenced literature article "a case report: retrograde arterial embolization of locally-injected spaceoar hydrogel material into the right common iliac artery bifurcation".The patient was placed in the lithotomy position, one percent of lidocaine was administered through the perineum to the deep tissues.The patient received three non-orthogonal gold radio-opaque fiducial markers.A well demarcated location of the saline without rectal wall infiltration (rwi) was confirmed since an injection of 10 ml normal saline was performed.Aspiration was done and it did not reveal blood return.The spaceoar vue injection encountered a greater amount of physical resistance.Post spaceoar injection the ultrasound demonstrated spaceoar hydrogel appropriately deposited within denonvilliers' fascia.During recovery the patient complained about numbness and migratory buttock, thigh, and right lower extremity (rle) pain.A pulse examination demonstrated a decreased right dorsalis pedis arterial pulse.The ct demonstrated hyperattenuating intraluminal material within and at the bi- furcation of the right internal and common iliac arteries.A non-contrast ct followed by a contrast ct revealed hyperattenuating material at the origin of the right profunda femoris artery.The patient was transferred to the emergency department, and he was treated with a heparin drip overnight which improved the rle pain, paresthesia, and dorsalis pedis pulse.However, a ct angiogram confirmed that the hydrogel was still present at the bifurcation of the right internal and common iliac artery, while the embolized hydrogel at the right profunda femoris artery origin had migrated distally overnight into the mid profunda femoris.The patient was then taken for an angiography to preform stent placement in order to exclude the hydrogel.A 12 mm x 60mm self-expandable medtronic protege fenestrated stent was deployed.In addition, a 13 mm x 50 mm balloon-expandable gore viabahn covered stent was also deployed with the intention of preventing a future embolization.Upon discharge, the patient was treated with oral eliquis for 3 months followed by 81 mg of aspirin until the hydrogel resorbs.A follow up ct abdomen after approximately 1.5 months after stent placements was performed and it demonstrated continued patency of the right common iliac artery stents, partial resorption of excluded hydrogel within the right internal iliac artery, and complete re- sorption of hydrogel at the right mid profunda femoris artery.

• Brand Name: SPACEOAR VUE SYSTEM
• Type of Device: ABSORBABLE PERIRECTAL SPACER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11761622
• MDR Text Key: 248561383
• Report Number: 3005099803-2021-01935
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/10/2021; 07/16/2021; 12/27/2022
• Supplement Dates FDA Received: 06/09/2021; 08/11/2021; 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male