MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Device Problem Break (1069)

Patient Problems Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Malaise (2359); Numbness (2415)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported that the coil broke and the patient had hypersensitivity reaction and other complications post procedure.On (b)(6) 2020, an interlock-35 coil was selected for use and inserted into a splenic artery aneurysm.Patient felt okay in recovery.However, post procedure, when the nurse had the patient up to ambulatory, she had a sudden sharp pain in the right upper quadrant of her abdomen (spleen area).The pain was an 8/10 and lasted for several weeks.A follow up scan indicated a splenic infarct and the patient was hospitalized for 3 day for pain management.The patient developed several symptoms and concerned about hypersensitivity reaction.The complications noted were hair loss, extreme fatigue, brain fog, numbness in the bilateral ring and pinky fingers, increase in mucus drainage, general malaise.Constant itching, angioedema in hands, feet, lips tongue and eyes, daily headaches.It was noted that one the coil broke during the procedure.

Event Description

It was reported that the coil broke and the patient had hypersensitivity reaction and other complications post procedure.On (b)(6) 2020, an interlock-35 coil was selected for use and inserted into a splenic artery aneurysm.Patient felt okay in recovery.However, post procedure, when the nurse had the patient up to ambulatory, she had a sudden sharp pain in the right upper quadrant of her abdomen (spleen area).The pain was an 8/10 and lasted for several weeks.A follow up scan indicated a splenic infarct and the patient was hospitalized for 3 day for pain management.The patient developed several symptoms and concerned about hypersensitivity reaction.The complications noted were hair loss, extreme fatigue, brain fog, numbness in the bilateral ring and pinky fingers, increase in mucus drainage, general malaise.Constant itching, angioedema in hands, feet, lips tongue and eyes, daily headaches.It was noted that one the coil broke during the procedure.It was further reported that at the end of october, patient manifested fatigue, headaches, hair loss and angioedema.Ct scan was performed and showed some coils that was left in the splenic artery, and on december, 5 percent necrosis was noted.Subsequently, it was planned to test for hypersensitivity to the metals but referal to a vascular surgery was considered for removal and splenectomy.

• Brand Name: INTERLOCK-35
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11333928
• MDR Text Key: 232054166
• Report Number: 2134265-2021-01745
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR