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

Catalog Number	170-03-40024
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	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested, but was not returned as it was discarded by the site.A review of the lot history record (lhr) confirmed that there were no non-conformances; the devices from this lot conform to their predetermined specifications, including for stent retention.The investigation determined that a definitive conclusive cause is not able to be assigned to the reported complaint.However, given that the target lesion was ultimately treated with a smaller stent, the reported advancement difficulty and stent dislodgement are likely due to smaller vessel diameter, lesion calcification, and/or other challenging 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
On (b)(6) 2018, a male patient presented for percutaneous coronary intervention (pci).After pre-dilating the mildly calcified, 50% stenosed lesion in the mildly tortuous mid right coronary artery (rca) with a 1.5mm balloon, a 4.0x24mm cobra pzf nanocoated stent delivery system was advanced toward the lesion with resistance felt when crossing a tight proximal rca lesion and continued resistance to the mid rca; when reaching the mid rca lesion the device was unable to completely cross and the stent dislodged.The stent was retrieved by advancing a smaller 1.5mm balloon into the stent, inflating the balloon (slightly expanding the stent), then retracting the stent into the sheath.The target lesion was treated with a 3.0mm non-celonova stent.There were no adverse patient sequelae.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: 7819531
• Report Number: 3009306400-2018-00034
• Device Sequence Number: 19444791
• Product Code: MAF
• UDI-Device Identifier: 00879397000937
• UDI-Public: (01)00879397000937(17)201031(10)1710024002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/27/2018

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: 10/31/2020
• Device Catalogue Number: 170-03-40024
• Device Lot Number: 1710024002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/27/2018
• 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