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

Model Number SO-2101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Cardiopulmonary Arrest (1765); Death (1802); Renal Failure (2041); Loss of consciousness (2418)

Event Date 08/24/2020

Event Type  Death  

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 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 was implanted during a spaceoar placement procedure performed on (b)(6) 2020.Reportedly, the patient felt uncomfortable during the insertion of the stepper probe.The probe was pulled out and reset.Fiducials were administered prior to spaceoar implantation.Additionally, the procedure was done under lidocaine local anesthesia.According to the complainant, prior to the procedure, the patient took hydrocodone/acetaminophen (5/325) and ativan for back pain and nausea.The spaceoar gel was injected and "appeared to be a good injection.It was level and good dispersion superior and inferior".It was reported that minutes after finishing the procedure, the patient suffered from a "heart attack".This was further clarified as the patient "started to get very red in the face, arching back, got very stiff" but he was still talking and stated that he was "ok but seemed to be having a bad back spasm".The patient started turning blue and pulse oximetry showed his oxygen saturation was dropping.The patient was started on 10l of oxygen and stopped responding verbally.Femoral and carotid pulses were initially present, but the patient was cycling between blueness and normal color as his oxygen saturation varied from 60%, 80%, 90%, and then down to 60% again.Emergency medical technicians (emts) arrived and performed chest compressions for 15 minutes.The patient was given 4mg of epinephrine and his pulse came back.During transport to the emergency room, the patient's pulse was lost.The result of a full electrocardiogram (ekg) in the emergency room (er) suggested the patient was in ventricular fibrillation (vfib) and not pulseless electrical activity (pea) as previously thought.The patient was "shocked and able to spontaneously breathe again".The patient developed disseminated intravascular coagulation (dic) and was bleeding from intravenous (iv) access sites, the nasogastric tube, and his foley catheter.According to the physician, the patient appeared to be in renal failure.The patient was intubated and admitted to the intensive care unit (icu).An echocardiogram (echo) was performed and the result showed the patient's heart was "ok and did not seem to be cardiogenic shock".On (b)(6) 2020, the patient underwent a brain computerized tomography (ct), abdomen and pelvis computerized tomography (ct), and the results showed no hemorrhage or retroperitoneal bleed.The lower-extremity non-invasive (leni) test of the legs bilaterally showed no evidence of blood clots.The injecting physician felt that the ct scans showed "space-oar gel present in the correct location and in a typical quantity for what he would expect after an injection".A chest x-ray performed on an unspecified date was "non-informative"; a ct angiogram was not performed.The injecting physician noted that there was "still no known etiology and it was likely that the patient would be moving towards comfort measures only and discontinuation of life support".On september 16, 2020 boston scientific corporation was made aware that the patient passed away on (b)(6) 2020.The etiology of the reported events and the cause of death were not provided to bsc.It was reported that an autopsy will be conducted, but the results have not been made available to boston scientific corporation.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10560725
• MDR Text Key: 207751289
• Report Number: 3005099803-2020-03858
• Device Sequence Number: 1
• Product Code: OVB
• UDI-Device Identifier: 00864661000102
• UDI-Public: 00864661000102
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2020

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?: No
• 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: 08/24/2020
• Initial Date FDA Received: 09/21/2020
• 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): Death; Other
• Patient Age: 66 YR