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

Model Number 83779

Device Problems Premature Activation (1484); Malposition of Device (2616); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2021

Event Type  malfunction  

Event Description

It was reported that the coil was deployed in a non-target location.A 4mm x 15cm interlock coil was selected for a type 2 endoleak repair performed by embolizing the inferior mesenteric artery (ima) from superior mesenteric artery (sma) via marginal artery of drummond.With a truselect catheter retrograde through the ima and in the aneurysm sac, an attempt was made to deploy the coil, but the coil did not pack or form appropriately.The coil maintained a linear shape within the patent channel of the abdominal aortic aneurysm (aaa) endoleak.As the coil was advanced through the catheter, the catheter began to kick back out of the aaa.Deployment was aborted, and the physician began retracting the coil back into the catheter.Approximately 50% of the coil was still out of the catheter in the aaa when the coil abruptly detached.The catheter was dislodged out of the aaa and into the ima.There was no way to redirect the microcatheter back into the aaa with half the coil still outside the tip of the catheter, so the coil was hydrostatically deployed to clear the catheter.While the intent was to place the coil within the aaa endoleak, it was ultimately placed in the ima.The coil was left in place since there was no safe way to remove it.Part of the coil was at the branch point of the superior rectal artery.No patient complications were reported.

• Brand Name: INTERLOCK
• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11977972
• MDR Text Key: 255940538
• Report Number: 2134265-2021-07494
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 08714729764960
• UDI-Public: 08714729764960
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132578
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: 83779
• Device Catalogue Number: 83779
• Device Lot Number: 0022541256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1