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

Catalog Number	1011734-33
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	01/25/2016
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.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 (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 the design, manufacture or labeling.
Event or Problem Description
It was reported that on (b)(6) 2013, the patient presented with silent ischemia.A 3.0x33mm xience prime stent was implanted in the mid right coronary artery (rca) lesion and a 3.5x33mm xience prime stent was implanted in the proximal rca.On (b)(6) 2016, in-stent restenosis of the proximal rca, 3.5x33mm xience prime stent was noted.On (b)(6) 2016, an atherectomy and balloon angioplasty was performed as treatment.The patients condition improved.There was no additional information 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: 6084223
• Report Number: 2024168-2016-07686
• Device Sequence Number: 757985
• Product Code: NIQ
• UDI-Device Identifier: 08717648177262
• UDI-Public: (01)08717648177262(17)131113(10)110274Y
• 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): 11/07/2016

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: 11/13/2013
• Device Catalogue Number: 1011734-33
• Device Lot Number: 110274Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/07/2016
• 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: 3.0X33MM XIENCE PRIME STENT ASPIRIN, CLOPIDOGREL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 74