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

Model Number SO-2101

Device Problem Positioning Problem (3009)

Patient Problems Headache (1880); Nausea (1970); Pain (1994); Vomiting (2144); Embolism/Embolus (4438)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(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.

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2021 at 11 a.M.The patient reported to the emergency room (er) with complaints of pain, nausea, and vomiting, 4 hours after the spaceoar procedure.It was found that the patient had various emboli of the spaceoar gel in the kidney, spleen, and liver.Additionally the patient complained of headaches.The patient will underwent additional brain imaging.As of (b)(6) 2021, additional information was received stating that the patient's head scan was negative.It was also found the patent has foramen ovale, indicating how the spaceoar gel travelled into the kidney, spleen, and liver.The patient was discharged and given an anticoagulant.Reportedly the patient is doing better.

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2021 at 11 a.M.The patient reported to the emergency room (er) with complaints of pain, nausea, and vomiting, 4 hours after the spaceoar procedure.It was found that the patient had various emboli of the spaceoar gel in the kidney, spleen, and liver.Additionally the patient complained of headaches.The patient will underwent additional brain imaging.As of october 12, 2021, additional information was received stating that the patient's head scan was negative.It was also found the patent has foramen ovale, indicating how the spaceoar gel travelled into the kidney, spleen, and liver.The patient was discharged and given an anticoagulant.Reportedly the patient is doing better.On november 1, 2021, additional information was received stating that the procedure was done under local anesthesia and the material that caused the emboli was suspected to be spaceoar hydrogel.The patient received antibiotics and may have received valium.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: medical device problem code a1502 captures the reportable event of gel misplaced, vascular.Clinical code e 9090 captures the reportable event of embolism.Clinical code e 9205 captures the reportable event of pain.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2021 at 11 a.M.The patient reported to the emergency room (er) with complaints of pain, nausea, and vomiting, 4 hours after the spaceoar procedure.It was found that the patient had various emboli of the spaceoar gel in the kidney, spleen, and liver.Additionally, the patient complained of headaches.The patient will underwent additional brain imaging.As of october 12, 2021, additional information was received stating that the patient's head scan was negative.It was also found the patent has foramen ovale, indicating how the spaceoar gel travelled into the kidney, spleen, and liver.The patient was discharged and given an anticoagulant.Reportedly the patient is doing better.On november 1, 2021, additional information was received stating that the procedure was done under local anesthesia and the material that caused the emboli was suspected to be spaceoar hydrogel.The patient received antibiotics and may have received valium.Additional information on january 12, 2023.It was reported the patient experienced an acute ischemic stroke with resultant left hemiplegia.There was evidence that an embolus occurred to the spleen and liver.The patient underwent anticoagulation, which improved the patient condition.However, the patient now walks with a cane.The patient proceeded with proton therapy for his prostate cancer and had undetectable prostate specific antigen (psa) with normal testosterone.

Manufacturer Narrative

Additional information block b5 and d6 have been updated with the additional information received on january 12, 2023.Additional information received update on the following: block b5:describe event or problem.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.Block h6: medical device problem code a1502 captures the reportable event of gel misplaced, vascular.Imdrf patient code e9090 captures the reportable event of embolism.Imdrf patient code e2330 captures the reportable event of pain.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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: SPACEOAR 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 12684313
• MDR Text Key: 278107380
• Report Number: 3005099803-2021-05475
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

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: SO-2101
• Device Catalogue Number: SO-2101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/01/2021; 01/12/2024
• Supplement Dates FDA Received: 11/29/2021; 02/06/2024
• 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