MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1125225-18
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Foreign Body In Patient (2687)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: dilatation catheter: 2.25 x 20 trek, 3.5x20 trek, guide wire: balance middle-weight universal, terumo run-through.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effect of angina is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and subsequent patient effects appear to be related to circumstances of the procedure as it is likely that the stent delivery system (sds) was difficult to position in the tight lesion resulting in the reported movement of the stent and subsequent partial expansion.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that on (b)(6)2017, the patient presented with a non st elevation myocardial infarction and unstable angina.A 2.25x18 mm xience alpine stent delivery system (sds) was advanced to the non-calcified lesion in the distal obtuse marginal (om) coronary artery and direct stenting was performed at 14 atmospheres for 20 seconds, but due to the tightness of the lesion, the stent moved 3 mm proximally on the balloon.After stent deployment, the proximal segment of the stent was not expanded and when the sds was retracted from the anatomy, the stent moved proximal into the proximal om, but the sds was successfully removed from the partially deployed stent.A 2.25x20 trek dilatation catheter was advanced through the stent, fully deploying it, but the stent moved into healthy tissue in the mid om.A 3.5x20 trek dilatation catheter was inserted and post dilated the stent.Another 2.25x18 xience alpine sds was inserted to be used in the distal om lesion, but was unable to cross through the implanted stent and was removed from the anatomy, undeployed.On the morning of (b)(6) 2017 the patient experienced chest pain and a minor, insignificant rise in troponin.No treatment was given and the chest pain resolved the same day.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7158705
• Report Number: 2024168-2018-00009
• Device Sequence Number: 16610147
• Product Code: NIQ
• UDI-Device Identifier: 08717648199080
• UDI-Public: 08717648199080
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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): 01/02/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: 1125225-18
• Device Lot Number: 7071961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 01/02/2018
• 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: Other
• Patient Age: 50 YR
• Patient Weight: 68