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

Catalog Number	1009541-18
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation; however, there was no reported device malfunction and the product was not returned.Stenosis is listed in the xience v everolimus eluting coronary stent systems instructions for use, as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The additional 2 xience v devices referenced are being filed under a separate medwatch mfr number.
Event or Problem Description
It was reported that on (b)(6) 2010, three xience v stents were implanted in the proximal right coronary artery, sizes 2.5 x 28mm, 3.0 x 18mm, 3.0 x 08mm.On (b)(6) 2011, restenosis was found in the lesion.The patient was hospitalized and was treated with pci for restenosis in the 2.5x28 xience v stent on (b)(6) 2011.The patient condition improved and was discharged from the hospital on (b)(6) 2011.On (b)(6) 2012, restenosis was found again in the lesion.The patient was hospitalized and was treated with a triple coronary artery bypass graft surgery in the distal left anterior descending coronary artery, the posterior-lateral branch of left circumflex coronary artery, and the arteriovenous branch of the right coronary artery on (b)(6) 2012.The patient condition improved and the patient was discharged from the hospital on (b)(6) 2012.No additional information was provided.

• Brand Name: XIENCE V 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: 5873610
• Report Number: 2024168-2016-05385
• Device Sequence Number: 18953067
• Product Code: NIQ
• UDI-Device Identifier: 08717648064111
• UDI-Public: (01)08717648064111(17)120629(10)0061741
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2016

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: 06/29/2012
• Device Catalogue Number: 1009541-18
• Device Lot Number: 0061741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2016
• Initial Report FDA Received Date: 08/12/2016
• 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; Disability
• Patient Age: 65 YR
• Patient Weight: 76