MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4770

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2019

Event Type  malfunction  

Manufacturer Narrative

The hyperform balloon has not been returned; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-00395, 2029214-2019-00396.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report of hyperform balloon rupture during a procedure.The patient was undergoing flow diversion treatment of a ruptured blister aneurysm in ophthalmic segment of internal carotid artery (ica).The aneurysm was reported to have a max diameter and a neck diameter of 2mm.The landing zone was 3.8mm distally and 4.3mm proximally.The anatomy was reported to have been normal in tortuosity.The devices were prepared as indicated in the ifu.A continuous flush was used during the delivery of the devices.During the procedure, a hyperform was used.While inflating, the balloon ruptured and leaked of contrast.The balloon was removed from the body.Angio revealed no patient injury.

Manufacturer Narrative

H3: the hyperform occlusion balloon catheter (model: 104-4770 lot: a488363) was returned for analysis within a shipping box; within an opened hyperform outer carton; within an opened hyperform inner pouch and within a dispenser coil.Upon visual inspection, no damages or irregularities were found with the hyperform occlusion balloon catheter hub.No bends or kinks were found with the hyperform catheter body or distal tip.The hyperform occlusion balloon catheter was flushed, water exited from the distal tip.In order to test the balloon for inflation, a mandrel was inserted into the distal tip of the balloon.An attempt was made to inflate the balloon; however, the balloon could not maintain inflation as it was found to be leaking distal to the distal marker.Upon microscopic examination, a defect (hole) in the chronoprene tubing was found at the location of the leak.No ¿ruptures¿ were found with the balloon.No other anomalies were observed.There was no indication that the event was related to a potential manufacturing issue.Based on the device analysis and reported information, the customer¿s report of ¿rupture¿ could not be confirmed as the balloon was not found to be ruptured.However, the device evaluation showed the balloon could not maintain inflation due to the defect (hole) in the chronoprene tubing.The defect observed is consistent with mechanical or navigation related damage rather than those caused by over-inflation (rupture).In this event use context likely contributed to the damage found with the balloon of the returned hyperform occlusion balloon catheter as the device was used for angioplasty of the pipeline flex embolization device (pli-30).There were no reported issues preparing the hyperform occlusion balloon catheter prior to use (which includes balloon inflation/deflation).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8559720
• MDR Text Key: 143371633
• Report Number: 2029214-2019-00397
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00847536005853
• UDI-Public: 00847536005853
• Combination Product (y/n): N
• PMA/PMN Number: K091458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2019
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: A488363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR