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

Catalog Number	170-03-35024
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	05/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested, but was not returned as it was retained 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 while a definitive conclusive cause is not able to be assigned to the reported complaint, the reported advancement difficulty and stent dislodgement are most likely due to the very sharp, hooked-shaped vessel, severe lesion calcification, and possible interaction with the previously deployed stent.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
After performing atherectomy and pre-dilatation, a cobra pzf nanocoated stent (size unspecified) was deployed in the very sharp, hooked-shaped ostial to proximal left anterior descending (lad) coronary artery without any reported issue.A 3.5x24mm cobra pzf nanocoated stent system was then advanced via groin access, to be placed in the severely calcified ostium of the lad, overlapping the previously deployed stent, but the device was unable to cross the remaining proximal lesion due to the sharp lad curve.During withdrawal, no resistance was felt, but stent slid off balloon during withdrawal; reportedly, the stent may have caught a proximal strut of the previously implanted stent due to the sharp lad bend.No guideliner was used.The dislodged stent was snared without issue.Another cobra was used to successfully treat the ostial lad lesion.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: 7584667
• Report Number: 3009306400-2018-00018
• Device Sequence Number: 1988333
• Product Code: MAF
• UDI-Device Identifier: 00879397000876
• UDI-Public: (01)00879397000876(17)200831(10)1708024001
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/08/2018

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: Physician
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 170-03-35024
• Device Lot Number: 1708024001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/08/2018
• 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