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

Model Number	170-03-35012
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The delivery system was requested but has not yet been received.The lot history record (lhr) review revealed no non-conformances related to the reported adverse event.The devices from this lot conforms to its predetermined specifications and requirements, including for stent retention.Dislodgement is captured in the risk assessment as a known potential hazard.Investigation is not yet complete.Additional relevant, significant information will be submitted in a follow-up report.
Event or Problem Description
On 22-november-2019, percutaneous coronary intervention (pci) was performed as follows for treatment of a lesion in the mildly tortuous mid left anterior descending (mlad) coronary artery: no pre-dilataiton was performed.A 3.5x12mm cobra pzf¿ nanocoated coronary stent system was unpackaged and prepped per usual procedure without issue; the technician observed the stent to remain on delivery system prior to use and handed off system to physician, who believed stent was on device.The delivery system was then inserted into guide catheter and advanced to lesion without difficulty and without resistance; the device was inflated at the lesion.Upon withdrawal of the delivery system, the physician noted that the stent was not at the lesion site and not on the delivery system.Stent was unable to be located via imaging.Although the stent was unable to be found in anatomy angiographically, or in the cath lab, the physician is unable to confirm if stent remains in patient anatomy.Plaque shift and dissections were noted on angiography, but were not flow-limiting.The target lesion was treated via deployment of a drug-eluting stent.No adverse events were noted during or immediately after pci.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 92008 8894
• MDR Report Key: 9480826
• Report Number: 3009306400-2019-00069
• Device Sequence Number: 366097
• Product Code: MAF
• UDI-Device Identifier: 00879397000845
• UDI-Public: (01)00879397000845(17)220831(10)1908264001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 170-03-35012
• Device Catalogue Number: 170-03-35012
• Device Lot Number: 1908264001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/17/2019
• 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
• Patient Age: 82 YR