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

Catalog Number	170-03-40012
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	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the stent dislodgement was confirmed.Failure to advance was unable to be replicated in a testing environment due to clinical operational / procedural factors that can be attributed to advancement difficulties.All stent delivery systems are 100% visually inspected online for stent placement.Based on the analysis of the stent and its delivery system, the returned device did not show any indication of device related issues or device deficiency that could have caused the reported failure to advance and stent dislodgement.Additionally, a sampling of units is destructively tested to verify stent dislodgement force.A review of the lot history record indicated that there were no non-conformances related to the reported difficulties for this lot.A risk assessment review confirmed that the reported failure to advance and stent dislodgement 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 stent dislodgement appear to be related to circumstances of the procedure.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
It was reported that on (b)(6) 2017, after pre-dilating the a moderately calcified lesion in the proximal circumflex coronary artery, a 4.0 x 12 mm cobra pzf stent delivery system (sds) failed to cross the lesion.The cobra sds was withdrawn, and additional pre-dilatation was performed.The same cobra sds was re-inserted, but upon exiting the guide catheter (ebu 3.5), it was noted that the stent was no longer on the balloon.All devices were withdrawn as a single unit and the stent came out along with the devices; the stent had dislodged at some point while entering patient vasculature.No force was applied at any time while using the cobra sds.A 3.5 mm cobra pzf successfully crossed and the stent was deployed.There were no adverse patient effects.No additional information was provided.

• Brand Name: COBRA PZF
• Common Device Name: STENT CORONARY DELIVERY SYSTEM
• Manufacturer (Section D): CELONOVA BIOSCIENCES, INC.; 8023 vantage dr.; suite 1500; san antonio TX 78230
• MDR Report Key: 7035450
• Report Number: 3009306400-2017-00015
• Device Sequence Number: 1745079
• Product Code: MAF
• UDI-Device Identifier: 00879397000906
• UDI-Public: (01)00879397000906(17)200331(10)1703294001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/15/2017

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: 03/31/2020
• Device Catalogue Number: 170-03-40012
• Device Lot Number: 1703294001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1