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

Catalog Number	1011731-38
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Estimated age: patient was born in (b)(6) 1956.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.The reported patient effect of stenosis is listed in the xience prime everolimus eluting coronary stent system, instructions for use as a known patient effect of coronary stenting procedures.Based on the case information, a conclusive cause for the reported patient effect 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 3.0 x 38 xience prime referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2013 three xience prime stents (sizes 2.5 x 38, 3.0 x 38, 3.5 x 18 mm) were implanted in the 75% stenosis in the left main trunk to treat an acute myocardial infarction.On (b)(6) 2016, restenosis (90%) was found in the 2.5 x 38mm and 3.0 x 38mm xience prime stents.These were treated with a cutting balloon and the event resolved.On (b)(6) 2017 ,restenosis (75%) was found in the 2.5 x 38mm and 3.0 x 38mm xience prime stents.These were treated with a drug eluting stent and the event resolved.No additional information was provided.

• Brand Name: XIENCE PRIME LL 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: 6599630
• Report Number: 2024168-2017-04598
• Device Sequence Number: 79161
• Product Code: NIQ
• UDI-Device Identifier: 08717648177033
• UDI-Public: (01)08717648177033(17)140128(10)2071641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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: 01/28/2014
• Device Catalogue Number: 1011731-38
• Device Lot Number: 2071641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 05/30/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 52