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

Model Number	170-03-40030
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested but has not yet been received.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, removal difficulty, and dislodgement are captured in the risk assessment as a known potential hazards.Investigation is not yet complete.A follow-up report will be submitted with additional relevant information.
Event or Problem Description
A (b)(6) male patient presented on (b)(6) 2019 for planned percutaneous coronary intervention (pci).Angiography showed a moderately calcified lesion in the severely tortuous mid right coronary artery (mrca) with a previously implanted stent in the proximal segment.The physician gained arterial access via the right radial artery.After pre-dilating the lesion with a 3.5 x 15 mm semi-compliant balloon, an attempt to cross was made with a 4.0 x 30 mm cobra pzf¿ nanocoated coronary stent system, but this device was unable to cross the lesion due to patient anatomy.During withdrawal, resistance was felt against the anatomy, and the stent dislodged in the proximal part of the rca.The dislodged stent was snared and retrieved from the vessel.A new, smaller stent (3.5 x 30 mm cobra pzf¿) was deployed in the mrca.There were no adverse patient sequelae.Though requested, no additional information was provided.
Additional Manufacturer Narrative
The device was received (b)(6) 2019.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, removal difficulty, and dislodgement are captured in the risk assessment as a known potential hazards.Complaints specialist received the delivery system in the following condition: dislodged stent stretched / damaged and hooked in snare device; balloon tightly folded and with crimp marks, indicating that stent was firmly crimped on balloon prior to reported event.Applicable dimensional analysis on the returned device met product specifications.Complaints specialist was unable to replicate the reported event in a testing environment due to the condition of the returned device and due to procedural, anatomical circumstances, and / or other uncontrolled factors possibly related to the procedure itself.Though unable to be confirmed, the cause of inability to cross, withdrawal difficulty, and dislodgement are most likely related to challenging vessel morphology (severe tortuosity and moderate calcification), stent size selection (as a smaller diameter was ultimately able to cross), and / or possible interaction with previously implanted stent in the proximal segment.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
A 60-year-old male patient presented on (b)(6) 2019 for planned percutaneous coronary intervention (pci).Angiography showed a moderately calcified lesion in the severely tortuous mid right coronary artery (mrca) with a previously implanted stent in the proximal segment.The physician gained arterial access via the right radial artery.After pre-dilating the lesion with a 3.5x15mm semi-compliant balloon, an attempt to cross was made with a 4.0x30mm cobra pzf¿ nanocoated coronary stent system, but this device was unable to cross the lesion due to patient anatomy.During withdrawal, resistance was felt against the anatomy, and the stent dislodged in the proximal part of the rca.The dislodged stent was snared and retrieved from the vessel.A new, smaller stent (3.5x30mm cobra pzf¿) was deployed in the mrca.There were no adverse patient sequelae.Though requested, no additional information was provided.Subsequent to the initial filed medwatch report, user facility medwatch report was received, and states the following: "describe the event or problem: physician inserted a stent into a patient's coronary artery.As the physician was taking the deployment system out, it was then noted that the undeployed stent came off the deployment system and was left in the coronary artery.Physician was able to snare the stent out of the artery and continue on with the procedure.What was the original intended procedure? stent deployment what problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do.".

• 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: 9174766
• Report Number: 3009306400-2019-00054
• Device Sequence Number: 2830441
• Product Code: MAF
• UDI-Device Identifier: 00879397000944
• UDI-Public: (01)00879397000944(17)210531(10)1805164004
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 12/19/2019

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 170-03-40030
• Device Catalogue Number: 170-03-40030
• Device Lot Number: 1805164004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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
• Patient Age: 60 YR
• Patient Weight: 79