MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that when the vad coordinator was unpacking the implant kit from its outer packaging, they saw that the implant kit seal was destroyed and it appeared that the kit had already been opened prior to the shipment.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the returned kit and submitted photograph for heartmate 3 left ventricular assist system (hm3 lvas), serial number (b)(6) confirmed that the top seal was broken.A specific cause for this finding could not be conclusively determined through this evaluation.Inspection of the lvas kit for (b)(6) confirmed that the sticker seal on the outer blue suitcase was broken.The packaging of the internal components was also inspected and was unremarkable.Given the fact that the center did not remove the products from their individual packaging, the packaging was left intact and no functional testing was performed.The issue of the top seal of the hm3 lvas kit being damaged was previously sent to abbott manufacturing.Although a specific root cause for the seal being broken could not be conclusively determined, the issue was determined to not be manufacturing related.The inspection steps that are currently in place would have captured the reported event of the hm3 implant kit seal being broken if the seal was broken while the kit was still within the control of abbott manufacturing.The issue of the top seal of the hm3 lvas kit being damaged was re-forwarded to abbott manufacturing under this complaint.Although there were no apparent manufacturing-related issues associated with this type of event, the decision was made to open an additional manufacturing analysis to evaluate potential improvements to the sticker seal design.It was concluded during the investigation that this type of event is not considered to be a manufacturing-related or design-related issue; material was a probable root cause, as the added bulk and weight of the printed instructions for use (ifu) cause stress on the seal.Abbott's conversion to electronic ifus may help to minimize this kind of event.It was decided that no further scoping, bracketing, or corrective actions are necessary.The relevant sections of the device history records for (b)(6)were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.Review of the lvas kit shop order showed that manufacturing applied the security label on (b)(6).Quality assurance inspected for correct labeling and any damage to the suitcase on (b)(6)2021.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 5 ¿surgical procedures¿ of this ifu contains information regarding the unpacking of the hm3 lvas kit.The ifu also warns that a complete backup system must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11324692
• MDR Text Key: 234483389
• Report Number: 2916596-2021-00758
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: 106524INT
• Device Lot Number: 7796884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1