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

Catalog Number	1003382-28
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816); Stenosis (2263)
Date of Event	07/09/2016
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.Date of implant - estimated.There was no reported device malfunction and the product was not returned as it remains implanted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and stenosis, as listed in ultra rapid exchange (rx) coronary stent system (css) instructions for use, are known patient effects that may be associated with use of a coronary stent in native coronary arteries.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The xience alpine stent is filed under medwatch #2024168-2016-05135.[(b)(4)].
Event or Problem Description
The following was reported via voluntary medwatch report (mw5076123): reporter stated she had a heart attack in 2016.She started off with a cardio rehab and instead of feeling better, felt worst.She had shortness of breath and went to the hospital.After cardiac monitoring, the drs discovered that the stent was 100% blocked.Reporter continues to experience symptoms of a heart attack in an attempt to clear the stent, the balloon blocked in the coronary artery.The drs pushed the balloon to the tip of artery and put a stent on each side of the artery to hold it in place.She was administered effient to prevent blood clots.Reporter is worried and afraid to travel out of or do anything for fear of dislocating the device.Reporter states that the manufacturer (mfr) refuses to take responsibility regarding this faulty device.The following additional information was received: in (b)(6) 2016, the patient experienced a heart attack and an ultra stent was implanted.On (b)(6) 2016, the patient experienced angina and shortness of breath and was hospitalized.Angiography revealed 100% stent restenosis and percutaneous coronary intervention was performed (see medwatch #2024168-2016-05135).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: 7469512
• Report Number: 2024168-2018-03139
• Device Sequence Number: 11164729
• Product Code: MAF
• UDI-Device Identifier: 08717648035326
• UDI-Public: 08717648035326
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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: 08/31/2017
• Device Catalogue Number: 1003382-28
• Device Lot Number: 5090341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/27/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 79