MAUDE Adverse Event Report: CELONOVA BIOSCIENCES, INC. COBRA PZF; STENT CORONARY DELIVERY SYSTEM

Model Number	170-03-30030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the stent remains implanted in the patient and there was no report of delivery system malfunction, the device was not requested.A review of the lot history record (lhr) was performed.There were no non-conformances related to the reported event.The lot conforms to its predetermined specifications and requirements.A review of instructions for use confirmed that perforation is labeled as known potential adverse event.Investigation is not yet complete.A follow-up report will be submitted with additional relevant information.
Event or Problem Description
During planned percutaneous coronary intervention (pci) for treatment of a lesion in a native (unspecified) coronary vessel at an unspecified date (on or before (b)(6) 2020), the lesion was prepped with a cutting balloon, followed by deployment of a 3.0x30mm (lot # 1703074001) cobra pzf nanocoated stent (at 18 atmospheres).After stent deployment, a perforation was observed and the patient began to code.While patient outcome is unknown, to date, the patient is not deceased.Additional information was requested.
Additional Manufacturer Narrative
B3 and d6 are estimated dates.B5 is revised.As the stent remains implanted in the patient and there was no report of delivery system malfunction, the device was not requested.A review of the lot history record (lhr) was performed.There were no non-conformances related to the reported event.The lot conforms to its predetermined specifications and requirements.A review of instructions for use confirmed that perforation is labeled as a known potential adverse event.A definitive root cause for the reported perforation is not able to be determined.As there were no reported device or labeling deficiencies, the perforation may have resulted from, but not limited to, stent or balloon overexpansion; incorrect stent size selection for vessel reference size; vessel pathology (including atherosclerosed vessel prepped with cutting balloon prior to stent use); excessive force required during advancement / retraction; and / or poor stent wall apposition.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling; there is no evidence of a device deficiency.
Event or Problem Description
During planned percutaneous coronary intervention (pci) for treatment of a lesion in a native (unspecified) coronary vessel at an unspecified date (on or before (b)(6) 2020), the lesion was prepped with a cutting balloon, followed by deployment of a 3.0x30mm (lot # 1703074001) cobra pzf nanocoated stent (at 18 atmospheres).After stent deployment, a perforation was observed and the patient began to code.While patient outcome is unknown, to date, the patient is not deceased.Though requested, no additional information was provided.

• Brand Name: COBRA PZF
• Common Device Name: STENT CORONARY DELIVERY SYSTEM
• Manufacturer (Section D): CELONOVA BIOSCIENCES, INC.; 5840 el camino real; suite 111; carlsbad, ca
• MDR Report Key: 9741639
• Report Number: 3009306400-2020-00009
• Device Sequence Number: 13946797
• Product Code: MAF
• UDI-Device Identifier: 00879397000821
• UDI-Public: (01)00879397000821(17)200331(10)1703074001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 03/31/2020
• Device Model Number: 170-03-30030
• Device Catalogue Number: 170-03-30030
• Device Lot Number: 1703074001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other