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

Catalog Number	170-03-40018
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	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with any additional relevant information.
Event or Problem Description
A (b)(6) year old male patient presented with lesions in the proximal and distal right coronary artery (rca).An attempt was made to cross the proximal lesion with a 4.0x18mm cobra pzf stent delivery system, but it was unable to cross due to vessel calcification.During withdrawal of the stent system through the touhy valve, the stent came off of the balloon.The dislodged stent was retrieved from inside of the touhy.The patient was successfully treated with a new 4.0x18mm cobra.There were no adverse patient effects.
Additional Manufacturer Narrative
Visual and dimensional testing was performed on the returned device.While the stent was received in a non-dislodged state, the returned device appears to have had its stent dislodged with the stent likely manually pushed back onto the balloon, as the sent was loose and not firmly crimped between the balloon markers (the user also indicated the stent was dislodged and was retrieved from the touhy valve).Damaged stent struts and kinked distal shaft confirm the reported crossing difficulty and retrieval from touhy valve.Crimp/pillow marks were visible on the balloon, indicating that the stent was firmly crimped on the balloon between the markers prior to dislodgement.Balloon fold creases were visualized, indicating that the balloon was not likely completely expanded, but the balloon is not tightly folded and the stent appears to have been slightly expanded, indicating that a slight inflation attempt by the user may have occurred, which may have affected stent retention.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.While a definitive conclusive cause is not able to be assigned to the reported complaint, evidence suggests that vessel calcification, inadvertent slight balloon/stent expansion, and stent system interaction with the tuohy hemostatic valve may contributed to the reported advancement difficulty and stent dislodgement.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
(b)(6) male patient presented with very calcified lesions in the proximal and distal right coronary artery (rca).An attempt was made to cross the proximal lesion with a 4.0x18mm cobra pzf stent delivery system, but it was unable to cross due to lesion calcification.During withdrawal of the stent system through the touhy valve, the stent came off of the balloon.The dislodged stent was retrieved from inside of the touhy.The patient was successfully treated with a new 4.0x18mm cobra.There were no adverse patient effects.

• 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: 7289082
• Report Number: 3009306400-2018-00008
• Device Sequence Number: 1892963
• Product Code: MAF
• UDI-Device Identifier: 00879397000920
• UDI-Public: (01)00879397000920(17)200831(10)1708094001
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 05/04/2018

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: Physician
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 170-03-40018
• Device Lot Number: 1708094001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR