MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Lot Number A262641

Device Problem Activation Failure (3270)

Patient Problems Paresis (1998); Perforation (2001)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as it remains implanted in the patient.Without return of the device we are unable to definitively determine the cause of the reported experienced.

Event Description

Medtronic received information that during treatment of an acom aneurysm the pipeline was constrained.It was reported that the pipeline was to cover partial proximal a2, acom, partial distal a1 and was constrained at the aneurysm neck, in the mid section of the pipeline.An attempt to open the pipeline was made by recapturing 3/4 of the pipeline and redeploying however the constrained segment was still present, and an attempt to bump after recapturing wire after full deployment however the constrain was still present.Therefore a non-medtronic balloon was taken up and 3 full inflation's of 30 sec or less were attempted, and after 3 inflation the balloon was removed.After initial run no contrast or vessel appeared on screen.A second attempt at run showed same result.The catheter was moved further proximally and new run taken, evidence of rupture was noted on 3rd run.The physician determined that there was a rupture at a1 which happened after 3rd inflation, proximal to proximal of the pipeline device.The physician determined that endovascular treatment was the best option, and took balloon back up and inflated at rupture site to stop hemorrhage.It was then decided to sacrifice the entire aca artery at distal a1.Coils were introduced to sacrifice a1 just proximal to proximal of the pipeline device.Four coils were placed to arrest blood flow, and case was deemed complete.The patient was reported paralyzed on one side.

Manufacturer Narrative

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: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6459130
• MDR Text Key: 71684049
• Report Number: 2029214-2017-00372
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• 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,Followup
• Report Date: 03/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: A262641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability