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

Catalog Number	1074250-23
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/29/2016
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.Stenosis is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.The bvs is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2013, a 2.5x18mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the distal left anterior descending (lad) coronary artery lesion and a 2.5x23mm xience xpedition stent was successfully implanted in the obtuse marginal (om) coronary artery lesion.During a follow-up, on (b)(6) 2016, restenosis was noted in the distal lad and om.Medication was provided.On (b)(6) 2016 the patient was hospitalized and another percutaneous intervention, placing a stent in the 90% restenosed distal lad scaffold and a stent in the obtuse marginal, 90% restenosed stent.The event resolved without sequela.On (b)(6) 2016, the patient was discharged from the hospital.There was no additional information provided.

• Brand Name: XIENCE XPEDITION 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: 6034154
• Report Number: 2024168-2016-07007
• Device Sequence Number: 77768
• Product Code: NIQ
• UDI-Device Identifier: 08717648162152
• UDI-Public: (01)08717648162152(17)150219(10)3013141
• 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): 10/17/2016

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: 02/19/2015
• Device Catalogue Number: 1074250-23
• Device Lot Number: 3013141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 10/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X18MM BVSASPIRIN, PRASUGREL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 64