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

Catalog Number	170-01-30018
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be filed with additional relevant information.
Event or Problem Description
On (b)(6) 2017, during a percutaneous coronary intervention (pci) procedure to implant a 4.0x30mm cobra pzf stent in left circumflex (lcx), pre-dilatation with a 2.5x15mm apex balloon was performed.Then, during advancement of the cobra pzf stent delivery system to the lcx lesion, it was unable to cross, reportedly due to vessel tortuosity and the stent dislodged in the patient.The whole dislodged stent was successfully retrieved using a gooseneck microsnare microcatheter.A 4.0x28mm drug-eluting stent (des) was then successfully implanted.There were no adverse patient sequelae.
Additional Manufacturer Narrative
Visual analysis was performed on the returned stent; the delivery system was reportedly discarded.The stent was confirmed to be dislodged and had incurred extensive damage; one end was narrowed while the other end was stretched and mangled with bent struts.The stent damage is likely due to the inability to cross and/or snaring / retrieval of the dislodged stent.Additional dimensional measurements and functional testing for both the inability to cross and dislodgement were unable to be performed due to the condition of the returned device.Receipt of the complete device may have further aided in the investigation.A review of the lot history record (lhr) confirmed that there were no non-conformances that occurred related to this, indicating that the devices from this lot conform to their predetermined specifications.The investigation determined that while a definitive conclusive cause is not able to be assigned to the reported complaint, the reported advancement difficulty and stent dislodgement appear to be related to circumstances of the procedure and or vessel morphology.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
N/a.
Additional Manufacturer Narrative
(b)(4).Revised per below: as there was no report of any device malfunction, the device was not requested for return.A review of the device lot history record indicates that the device from this lot met its predetermined specifications and requirements.A review of the patient hospitalization report ((b)(6) 2018) by celonova medical affairs confirmed that the cobra stent implanted in mid lad was patent.Additionally, there was no device malfunction, and the investigator determined that the mi is not related to the index procedure or the implanted cobra study device.The sponsor agrees with this assessment.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.
Additional Manufacturer Narrative
H2 correction: b3 event date corrected.
Event or Problem Description
Na.

• 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 CA 92008 8894
• MDR Report Key: 7245812
• Report Number: 3009306400-2018-00007
• Device Sequence Number: 164984
• Product Code: MAF
• UDI-Device Identifier: 00879397000944
• UDI-Public: (01)00879397000944(17)200731(10)170713400
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/27/2020

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 170-01-30018
• Device Lot Number: 1703014001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 03/21/2018; 07/17/2020
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/13/2018; 03/21/2018; 07/27/2020
• 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: Required Intervention
• Patient Age: 80 YR