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

Model Number	170-03-35030
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	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested but was discarded by the site.A review of the lot history record (lhr) was performed.There were no non-conformances.The devices from this lot conforms to their predetermined specifications and requirements, including for crossing profile and stent retention.Inability to cross and dislodgement are captured in the risk assessment as a known potential hazards.A review of received angiography images was unable to confirm the reported inability to cross or dislodgement.The investigation determined that a definitive conclusive cause is not able to be assigned to the reported complaint.Though unable to be confirmed, the cause of inability to cross and dislodgement are most likely related to severe lesion calcification and / or possible interaction with the guide catheter during withdrawal.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.The other cobra pzf device referenced is being reported under a separate mfr number (3009306400-2019-00066).
Event or Problem Description
A female patient presented for planned percutaneous coronary intervention (pci).Angiography performed on (b)(6) 2019 showed a severely calcified lesion in the ostial right coronary artery (rca) and proximal left anterior descending (lad) coronary artery.The physician gained arterial access via the right superficial femoral artery.A 4.0x30mm cobra pzf¿ nanocoated coronary stent was advanced and deployed in the proximal lad without issue.The rca lesion was prepped via atherectomy.An attempt was then made to cross the calcified ostial rca lesion with two cobra pzf¿ nanocoated coronary stent systems (3.5x30mm then a 3.5x24mm), but each stent system was unable to cross due to the severe calcification.After crossing attempt, each stent dislodged during retraction inside of a 7f guide catheter.In each occurrence, the stent and guide catheter were retrieved as single unit without injury to patient.A 3.5x16mm drug-eluting stent ultimately crossed and was deployed in the rca.Though requested, no additional information was provided.
Additional Manufacturer Narrative
The device was requested but was discarded by the site.A review of the lot history record (lhr) was performed.There were no non-conformances.The devices from this lot conforms to their predetermined specifications and requirements, including for crossing profile and stent retention.Inability to cross and dislodgement are captured in the risk assessment as a known potential hazards.A review of received angiography images was conducted by celonova medical affairs.Good guide catheter engagement into the rca was observed, as well as severe calcification and horizontal c bend right after the ostium, followed by a second vertical c bend in the proximal section.The reported inability to cross and dislodgement were not observed in the provided imaging.The investigation determined that a definitive conclusive cause is not able to be assigned to the reported complaint.Though unable to be confirmed, the cause of inability to cross and dislodgement are most likely related to severe lesion calcification and / or possible interaction with the guide catheter and / or hemostatic valve during withdrawal.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
Subsequent to the initial filed medwatch report, additional information was received from the physician, resulting in the following revised narrative: a female patient presented for planned percutaneous coronary intervention (pci).Angiography performed on 21-oct-2019 showed a severely calcified lesion in the ostial right coronary artery (rca) and proximal left anterior descending (lad) coronary artery.The physician gained arterial access via the right superficial femoral artery.A 4.0x30mm cobra pzf¿ nanocoated coronary stent was advanced and deployed in the proximal lad without issue.The rca lesion was prepped via atherectomy.An attempt was then made to cross the calcified ostial rca lesion with two cobra pzf¿ nanocoated coronary stent systems (3.5x30mm then a 3.5x24mm), but each stent system was unable to cross due to the severe calcification.After crossing attempt, each stent dislodged in the hemostatic valve after retraction through the 7f guide catheter.In each occurrence, the stent was retrieved from the hemostatic valve without injury to patient.A 3.5x16mm drug-eluting stent ultimately crossed and was deployed in the rca.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: 9335740
• Report Number: 3009306400-2019-00065
• Device Sequence Number: 419664
• Product Code: MAF
• UDI-Device Identifier: 00879397000883
• UDI-Public: (01)00879397000883(17)220731(10)1907084004
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/03/2019

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: 07/31/2022
• Device Model Number: 170-03-35030
• Device Catalogue Number: 170-03-35030
• Device Lot Number: 1907084004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 7F CORDIS JL 4 SH; GUIDE WIRE: 0.014X180 RUNTHROUGH