MAUDE Adverse Event Report: ATRICURE, INC. ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP

Model Number	ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The applier for lot number 98246 was not returned, only the clip portion, a device history review was obtained for the lot number assembly.There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.
Event or Problem Description
It was reported that a (b)(6) male patient with a history of pericarditis, afib and hypertrophic cardiomyopathy underwent an off-pump laam via left sided mini thoracotomy.The left lung was adhered to the pericardium and lung adhesions were dissected.Surgeon also noted large amount of pericardial adhesions.A prov50 clip was placed on the laa and tee was performed and noted that the laa was still patent.Surgeon opened the distal end of clip blood was noted.The clip was closed but bleeding was still evident, so the physician converted to a thoracotomy.The prov50 clip was removed from the laa, the laa was excised and a piece of bovine pericardium was used to close the la.At close of procedure the patient was stable, intubated, and transferred to cvicu for recovery.There was no reported device malfunction, and the adverse event was the result of a procedural complication.

• Brand Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP
• Common Device Name: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• MDR Report Key: 12453322
• Report Number: 3011706110-2021-00039
• Device Sequence Number: 19817176
• Product Code: PZX
• UDI-Device Identifier: 00818354015157
• UDI-Public: 00818354015157
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGRO
• Device Catalogue Number: A000974
• Device Lot Number: 98246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KITTNER, ENDOKITTNER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 79