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

Model Number	170-03-25030
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient initials are (b)(6).Both stent and delivery system are reportedly returning but have not yet been received.A review of the lot history record (lhr) was performed.There were no non-conformances observed for this lot that and the lot conforms to its predetermined specifications and requirements, including for stent retention.A review of instructions for use (ifu) was conducted.Inability to cross, removal difficulty, and stent dislodgement are listed in the ifu as known potential adverse events.Investigation is not yet complete.A follow-up report will be submitted with any additional relevant information.It should be noted: the cobra pzf stent ifu (section 6.8 precautions: stent system removal) states: remove the entire system as a single unit if: unable to cross the lesion easily.Resistance is encountered anytime during either stent advancement across the lesion or removal of the delivery catheter after deployment.(b)(4).
Event or Problem Description
On (b)(6) 2018, a (b)(6) year old male patient presented with two-vessel disease with calcification.During percutaneous coronary intervention (pci) for treatment of proximal and distal lesions in the tortuous right coronary artery (rca), a 2.5x30mm cobra pzf nanocoated coronary stent system was advanced past the mid rca with difficulty crossing the mid rca at the bend.After crossing the mid rca, numerous attempts were made to cross the distal rca lesion, but the device was unable to cross, despite pushing against resistance.The physician then decided to withdraw the stent system to alternatively treat the lesions with two smaller stents, however, upon withdrawal into the 6fr guideliner catheter, resistance was felt against the guideliner and the stent was stripped off of the balloon at the guideliner.After approximately 30 minutes, the dislodged stent was snared using an en snare device.Treatment of the target lesions was aborted.The patient was stable at the conclusion of the procedure with no reported adverse sequelae.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
• Manufacturer Contact: stephanie fossat-dominguez ; 5840 el camino real; suite #111; carlsbad, ca ; 6035617
• MDR Report Key: 7524467
• Report Number: 3009306400-2018-00011
• Device Sequence Number: 3131695
• Product Code: MAF
• UDI-Device Identifier: 00879397000708
• UDI-Public: (01)00879397000708(17)200831(10)1708174001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P160014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 08/31/2020
• Device Model Number: 170-03-25030
• Device Catalogue Number: 170-03-25030
• Device Lot Number: 1708174001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 05/17/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPPORT CATHETER: 6FR GUIDELINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 132 KG