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

Catalog Number	170-03-25018
Medical Device Problem Codes	Unstable (1667); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received 19-ov-2018.During visual inspection on 03-dec-2018 it was noted that the stent was shifted distally and was loose on the balloon, but the stent remained between the balloon marker bands and was not able to be pushed past the distal balloon marker.A review of the lot history record (lhr) was performed.There were no non-conformance's for this lot.The lot conforms to its predetermined specifications and requirements, including for crossing profile and stent retention.A risk assessment review confirmed that the reported advancement difficulty and loose stent are captured as foreseeable events.Investigation is not yet complete.A follow-up report with relevant additional information will be submitted.While celonova biosciences was made aware of inability to cross on (b)(6) 2018, the loose stent was noted on (b)(6) 2018; thus, reportability aware date is (b)(6) 2018.
Event or Problem Description
On (b)(6) 2018, a (b)(6) female patient presented for percutaneous coronary intervention (pci) of an unspecified vessel.During pci a 2.5x18mm cobra pzf coronary stent system was advanced but was unable to cross.There were no adverse patient effects.The device was received by celonova biosciences in the following condition: the stent was shifted distally and was loose on the balloon, but the stent remained between the balloon marker bands and was not able to be pushed past the distal balloon marker.Additional information was requested.
Event or Problem Description
On (b)(6) 2018, a 79-year-old female patient presented with a non-st-elevated myocardial infarction (nstemi).Percutaneous coronary intervention (pci) of a chronic total occlusion (cto) in the moderately tortuous left circumflex coronary artery (lcx) was performed.During the pci, the cto was pre-dilated, then a 2.5x18mm cobra pzf coronary stent system was advanced via right radial access but was unable to cross due to patient anatomy (cto).The patient was alternatively treated via balloon angioplasty (poba).The patient was scheduled to return for future pci.There were no adverse patient effects and no significant delay.The device was received by celonova biosciences in the following condition: the stent was shifted distally and was loose on the balloon, but the stent remained between the balloon marker bands and was not able to be pushed past the distal balloon marker.Though requested, no additional information was provided.
Additional Manufacturer Narrative
Event revised.Method code 10 added.Results code 3233 replaced with 3207.Conclusion code 11 replaced with 4315.The device was received.During visual inspection on 03-dec-2018 it was noted that the stent was shifted distally and was loose on the balloon, but the stent remained between the balloon marker bands and was not able to be pushed past the distal balloon marker.A review of the lot history record (lhr) was performed.There were no non-conformances for this lot.The lot conforms to its predetermined specifications and requirements, including for crossing profile and stent retention.A complaints record review was conducted for this reported part & lot combination.No other incidents were reported for this part & lot combination.A risk assessment review confirmed that the reported advancement difficulty and loose stent are captured as foreseeable events.The investigation determined that while a definitive conclusive cause is not able to be assigned to the reported complaint, the reported advancement difficulty and bent strut appear to be related to patient anatomy (moderately tortuous vessel with chronic total occlusion).Potential causes of resistance during advancement with resultant stent damage include: difficult (calcified / tortuous) anatomy; incorrect selection of stent system size for reference vessel diameter; stent system crossing profile too large; insufficient pushability, insufficient coverage of, or lack of, or degradation of, lubricity coating; defect in catheter body bond; handling damage; and / or delivery system tip too large.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.

• 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: 8197791
• Report Number: 3009306400-2018-00083
• Device Sequence Number: 1592885
• Product Code: MAF
• UDI-Device Identifier: 00879397000685
• UDI-Public: (01)00879397000685(17)200930(10)1709124002
• 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,Followup
• Report Date (Section B): 01/31/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 170-03-25018
• Device Lot Number: 1709124002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR