MAUDE Adverse Event Report: AV-TEMECULA-CT ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

Catalog Number	1003381-18
Health Effect - Clinical Codes	Dyspnea (1816); Respiratory Failure (2484)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 manufacture, design or labeling of the device.
Event or Problem Description
It was reported that a us rx ultra 9-cell 4.5/18 mm stent was implanted on (b)(6) 2017 in the mid-circumfex artery after thrombectomy and post-dilated with a 4.5 non-compliant balloon reducing 100% stenosis to 0 with timi 3 flow.The patient was re-admitted on (b)(6) 2017 with shortness of breath and respiratory failure.Treatment included a ventilator and diuresis.The patient was discharged on (b)(6) 2017 back to the nursing home where he resides.No additional information was provided.

• Brand Name: ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6638937
• Report Number: 2024168-2017-05046
• Device Sequence Number: 16347608
• Product Code: MAF
• UDI-Device Identifier: 08717648035272
• UDI-Public: (01)08717648035272(17)180831(10)6091941
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2017

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 Expiration Date: 08/31/2018
• Device Catalogue Number: 1003381-18
• Device Lot Number: 6091941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 06/13/2017
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 44