MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

Catalog Number	1008193-20
Health Effect - Clinical Codes	Stroke/CVA (1770); Coma (2417)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: stent: 8tx40x136 xact.Embolic protection device: emboshield nav6 lg 190cm.(b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.It should be noted that the viatrac instructions for use(ifu) states that the viatrac 14 plus peripheral dilatation catheter is intended: to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries).The reported patient effect of cerebrovascular accident, as listed in the viatrac instructions for use (ifu), is a known adverse event associated with the use of a peripheral device in native peripheral arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The emboshield nav6 device referenced is being filed under a separate manufacturing report number.
Event or Problem Description
It was reported that on (b)(6) 2017, the procedure was to treat a heavily calcified lesion in the moderately tortuous left internal carotid artery (lica).An emboshield nav6 lg 190cm embolic protection system (eps) was advanced past the lesion without issue.A 5x20x135 rx viatrac balloon was advanced and inflated without difficulty when, during inflation, the patient breathing became notably very labored then patient become totally unresponsive neurologically.No thrombus was noted, but a stroke was confirmed to have occurred.An 8tx40x136 xact stent was then successfully deployed, as planned, resulting in good flow and good overall result, as confirmed angiographically and on computerized tomography scan.The nav6 was retrieved without difficulty.No interventions were performed.While there were no device issues, the patient neurological deficit remains and patient remains comatose (but not intubated) and, as of (b)(6) 2017, is not expected to recover in the near future.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6603329
• Report Number: 2024168-2017-04655
• Device Sequence Number: 1170591
• Product Code: LIT
• UDI-Device Identifier: 08717648056987
• UDI-Public: (01)08717648056987
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1008193-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 05/31/2017
• 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: Disability
• Patient Age: 75 YR