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

Catalog Number	1011733-33
Health Effect - Clinical Codes	Death (1802); Stenosis (2263)
Date of Event	09/18/2013
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.Concomitant medical products: stent: nobori 3.0x18, promus element 2.5x38; aspirin.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.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.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 of the device.
Event or Problem Description
It was reported that on (b)(6) 2013, the patient presented with a stenosed bypass graft.A 3.0x33 xience prime stent was successfully implanted along with 2 non-abbott stents in the proximal to distal right coronary artery (rca) totally occluded lesion.On (b)(6) 2013, the patient presented for a follow-up coronary angiogram without any clinical symptoms.Approx 41.63% stenosis was noted in the 3.0x33 xience prime stent.Additional balloon angioplasty was performed as treatment.Medications were changed.On (b)(6) 2016 follow-up coronary angiography was performed.It was confirmed that there was no issue with any index procedure stent.On (b)(6) 2016, sepsis caused by acute gallbladder disease was diagnosed.No treatment was provided and later that day, the patient expired.Per the physician, the death was not related to the implanted stents or study procedure.There was no additional information received regarding this event.

• 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: 6316286
• Report Number: 2024168-2017-01097
• Device Sequence Number: 16395815
• Product Code: NIQ
• UDI-Device Identifier: 08717648177187
• UDI-Public: (01)08717648177187(17)140916(10)2090541
• 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): 02/09/2017

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: 09/16/2014
• Device Catalogue Number: 1011733-33
• Device Lot Number: 2090541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Initial Report FDA Received Date: 02/09/2017
• 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: 76 YR
• Patient Weight: 48