MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA STRAIGHT MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 439888

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/04/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during a system upgrade procedure, the patient experienced pericardial effusion and cardiac tamponade during the placement of the left ventricular (lv) lead.It was suspected that the blood vessel was damage when the physician was attempting to gain access to the posterolateral cardiac vein using a guidewire.The doctors attempted to rescue the patient using various methods, but they were unsuccessful.The patient is deceased.

• Brand Name: ATTAIN PERFORMA STRAIGHT MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12836434
• MDR Text Key: 280957611
• Report Number: 2649622-2021-23038
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 00643169601857
• UDI-Public: 00643169601857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: 439888
• Device Catalogue Number: 439888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/18/2021
• Date Device Manufactured: 06/28/2021
• 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): Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 98 KG