MAUDE Adverse Event Report: MPRI ATTAIN ABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 419688

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/20/2016

Event Type  Injury  

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.

Event Description

It was reported that during the implant procedure, patient experienced a pericardial effusion and cardiac tamponade due to a perforation.It was not known at which point the effusion occurred and what product was related to the effusion.It was noted the right atrial (ra) lead and right ventricular (rv) lead were placed and the physician inserted the balloon catheter into the coronary sinus, however, the x-ray did not show a brighter balloon silhouette as expected when the balloon was inflated.The physician performed the venogram and the fluid flushed away in the coronary sinus, as if the balloon was not inflated.The physician removed the balloon catheter and inflated the balloon outside the patient, however, it would not deflate after disconnecting the syringe and the valve.The balloon catheter was discarded and the physician chose to insert a different balloon catheter; it was added the physician may have repositioned the balloon while the balloon was already inflated within the coronary sinus.The venogram was performed and there were no signs of a perforation, dissection or contrast fluid within the pericardium at this point.The physician first chose to implant the left ventricular (lv) lead in a thinner antero-lateral vein, however, it was then decided to put the lv lead in the normal sized, postero-lateral vein and the lv lead was fixated.During slitting of the delivery catheter, the lv lead dislodged and slipped back into the coronary sinus and the lv lead implant attempt had to be restarted.In the meantime, both the right ventricular (rv) lead and right atrial (ra) lead fell off and needed to be repositioned.The second attempt to cannulate the coronary sinus with a new delivery catheter was more difficult and it was decided to implant an active fixation lv lead.It was noted at some point during the implant of the second lv lead, the patient status became critical for the first time; the patient's blood pressure was low, their skin color became whiter and the patient vomited.The physician then began to fixate the leads and implanted the cardiac resynchronization therapy pacemaker (crt-p).It was at the same time, another physician confirmed a pericardial effusion via ultrasound and the physician began pericardiocentesis to remove the blood from the pericardium.Since the device was not able to utilize telemetry c until after the pocket was closed, the leads were connected and the incision was seemed.It was then noticed the ra lead and rv lead were connected to the wrong ports in the crt-p and the pocket had to be re-opened.During the re-opening of the pocket, the ra and rv lead fell off again and needed to be repositioned; the lv lead then fell out of the coronary sinus.The patient status then became more critical and cardiopulmonary resuscitation (cpr) was performed, along with the use of a chest compression system for approximately thirty minutes.The physician then placed the existing ra lead into the right ventricle, and the rv lead and lv lead were explanted.It was decided to insert pin plugs into the ra port and lv port of the crt-p and utilize the chest compression system with medication until the patient was stable.The crt-p was programmed to vvi mode and the rv lead and crt-p remain in use.It was noted there was no evidence as to what could have caused the pericardial effusion and all of the attempted products were suspected to be related to the effusion.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN ABILITY
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6164223
• MDR Text Key: 62084636
• Report Number: 2649622-2016-16048
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Model Number: 419688
• Device Catalogue Number: 419688
• Device Lot Number: PVI784607V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2016
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 87 YR