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

Catalog Number	170-03-25012
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient and the delivery system was requested for return, but has not been received.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 crossing profile and stent retention.Inability to cross and dislodgement are captured in the risk assessment as known potential hazards.Loss of stent during advancement against resistance is labeled as a known potential adverse event.Investigation is not yet complete.A follow-up report will be filed with additional information.
Event or Problem Description
On (b)(6) 2018, (b)(6)-year-old patient with coronary artery disease with vessel calcification and tortuosity presented with a non-st-elevated myocardial infarction (nstemi).A heavily calcified lesion in the tortuous obtuse marginal (om) was identified.After pre-dilating the vessel, a 2.75x12mm cobra stent was deployed in the proximal to mid om without issue.An attempt was then made to cross this stent via right radial access for treatment of the distal om as follows: a 2.5x12mm cobra pzf nanocoated stent system was advanced over a whisper es 190cm guide wire, and through a 5f al1 lbt guide catheter, but, despite pushing the device against resistance, it was unable to cross the 1st stent due to tortuosity and severe calcification.While retracting the stent system, the stent stripped (dislodged) off of the balloon.Attempts were made to snare the stent using a 2nd guide wire and a balloon, but it was unable to be retrieved and it remains in the anatomy.As the target lesion was pre-dilated, the physician felt that this treatment was sufficient and left the distal om lesion as is.There were no adverse patient sequelae.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: 8217769
• Report Number: 3009306400-2018-00087
• Device Sequence Number: 16209366
• Product Code: MAF
• UDI-Device Identifier: 00879397000661
• UDI-Public: (01)00879397000661(17)200930(10)1709184002
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 09/30/2020
• Device Catalogue Number: 170-03-25012
• Device Lot Number: 1709184002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 01/04/2019
• 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: GUIDE CATHETER: 5F AL1 LBT; GUIDE WIRE: WHISPER ES 190CM; STENT: 2.75X12MM COBRA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Weight: 94