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

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

Patient Problems High Blood Pressure/ Hypertension (1908); Pleural Effusion (2010); Shock (2072); Thrombocytopenia (4431); Ruptured Aneurysm (4436); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/09/2019

Event Type  Injury  

Event Description

It was reported via a journal article that patient compilations occurred.In total, 32 patients were included in this study (18 women, 14 men; average age, 43 years; range, 23 to 56 years).All aneurysms were located in the main splenic artery (5 in the proximal part of the splenic artery, 12 in the middle part, and 15 in the distal part).Eleven (34%) patients had portal hypertension, 10 had abdominal pain, and 4 had back pain.One patient was diagnosed with a ruptured aneurysm during pregnancy.The remaining six patients were asymptomatic.The baseline characteristics of the patients and aneurysms are shown in table 1.All 32 aneurysms (mean size, 29.4, 6.9 mm; range, 20 to 43 mm) were successfully embolized with coils during the first procedure, with complete cessation of contrast flowing into the aneurysm.The technical success rate was 100%.Two (6%) of the 32 patients exhibited recurrent aneurysm flow during follow-up.Repeat intervention was performed to exclude the aneurysm.One of the two patients was a 23-year-old woman who was diagnosed with a ruptured saa during pregnancy (figure 1(a) through (c)).The patient presented with hemorrhagic shock upon admission.After a rapid multidisciplinary consultation involving specialists in obstetrics and gynecology, general surgery, and interventional medicine, intracavitary treatment was deemed necessary.Angiography and coil embolization were urgently performed to ensure bleeding control immediately after the procedure (figure 1(d)).However, the aneurysm recurred 6 months later (figure 1(e)).The catheter was advanced through the collateral feeding artery to further densely embolize the aneurysm sac with coils (figure 1(f)).The aneurysm was completely occluded during the 4-year follow-up (figure 1(g), (h)).In the other patient with recurrent aneurysm flow, repeat intervention was per formed 3 months after the first procedure.The recurrent aneurysm was managed with reperfusion of the collateral branch afferent to the left gastric artery.The aneurysm and target vessel were catheterized and coil embolized.No evidence of aneurysm rupture or enlargement was found in the other 30 (94%) patients during the follow up period (mean, 36 months; range, 6 to 72 months), and the clinical success rate was 94%.

Manufacturer Narrative

Date of event: article publication date used.(b)(6).Wang, wujie, et al."long-term outcomes of elective transcatheter dense coil embolization for splenic artery aneurysms: a two-center experience." journal of international medical research 48.1 (2020): 0300060519873256.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14846217
• MDR Text Key: 295117584
• Report Number: 2134265-2022-07451
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention