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

Model Number	170-03-35015
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	03/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent (without delivery system) was received 03-apr-2020.The site had indicated that they returned all that was retained (which was only the stent).Complaints specialist performed applicable visual analysis on the used returned stent; the delivery system was not returned.Complaints the center section of stent appeared to be stretched and slightly expanded with slightly rotated / twisted individual struts.A review of the lot history record (lhr) was performed.There were no non-conformances.The lot conforms to its predetermined specifications and requirements, including for stent retention.Risk assessment review indicates that stent dislodgement and vascular trauma (dissection) are captured as known potential occurrences.Dislodgement (ex-vivo) root cause: the investigation determined that a definitive conclusive cause is not able to be assigned to the reported complaint.Though unable to be confirmed, potential causes of dislodgement ex-vivo may include inadvertent rough handling during sheath removal and/or inadvertent slight inflation of balloon prior to sheath removal as the received stent appeared to be stretched and slightly expanded with slightly rotated / twisted individual struts; indicating that inadvertent inflation of the delivery system and / or handling damage may have occurred during unpackaging.Dissection root cause: in general, dissection can result from overexpansion of the stent; disruption of the stent during withdrawal once balloon is deflated; migration of stent from original position before or during stent re-expansion attempt; subsequent deployment of another overlapping stent; and /or sharp edge or damage on catheter tip.While the exact cause of dissection is unable to be determined in this case, patient comborbidities and vessel morphology are the most probable contributors to dissection as the stent was not on the balloon when the device was expanded.However, a relationship between the cobra delivery system and reported dissection cannot be completely excluded.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 (b)(6) year old male patient with a medical history of coronary artery disease, diabetes mellitus type 2, hypertension, dyslipidemia, and ex-smoker presented with stable angina and atrial fibrillation.The patient enrolled in a cobra trial.On (b)(6) 2020, diagnostic angiography showed a 70-90% stenosis in the proximal left anterior descending (lad) coronary artery, and 70% stenosis in marginal branch.After pre-dilating the lesion, a 3.5x15 cobra pzf¿ nanocoated coronary stent system was unpackaged when the stent came off of the balloon in the stylet (sheath) prior to use.The dislodgement was not yet detected until the delivery system was advanced then deployment attempt made; it was then discovered that the stent had dislodged outside of patient (in sheath) prior to use.When inflating the delivery system, (perceived as deployment attempt), a dissection occurred.A 3.5x30mm cobra stent was then deployed over the lesion and to treat the dissection successfully.There were no reported adverse patient sequelae and the patient discharged on (b)(6)2020.

• 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
• MDR Report Key: 10002061
• Report Number: 3009306400-2020-00017
• Device Sequence Number: 2968555
• Product Code: MAF
• UDI-Device Identifier: 00879397000852
• UDI-Public: (01)00879397000852(17)220531(10)1905024001
• Combination Product (Y/N): N
• 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): 04/27/2020

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: 05/31/2022
• Device Model Number: 170-03-35015
• Device Catalogue Number: 170-03-35015
• Device Lot Number: 1905024001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/27/2020
• 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: 78 YR
• Patient Weight: 81