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

Catalog Number	170-03-25018
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device is returning, but has not yet been received by celonova biosciences.A review of the lot history record (lhr) was performed.There were no non-conformances.The lot conforms to its predetermined specifications and requirements, including for stent retention.Stent dislodgement is captured in the risk assessment as a known potential hazard.Investigation is not yet complete.A follow-up report with relevant additional information will be submitted.
Event or Problem Description
On (b)(6) 2018, during percutaneous coronary intervention (pci) procedure for treatment of an unspecified coronary vessel, a 2.5x18mm, cobra pzf nanocoated coronary stent system was advanced then was withdrawn, undeployed, for an unspecified reason.Prior to attempting re-insertion of the stent system, the physician noted that the stent had dislodged from the stent delivery system, outside of patient anatomy.No adverse patient effects were reported.Additional information was requested.

• 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 92008 8894
• MDR Report Key: 8208138
• Report Number: 3009306400-2018-00084
• Device Sequence Number: 207605
• Product Code: MAF
• UDI-Device Identifier: 00879397000685
• UDI-Public: (01)00879397000685(17)201231(10)1712224001
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: 160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 170-03-25018
• Device Lot Number: 1712224001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 93