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	Ischemia (1942); Stenosis (2263)
Date of Event	07/15/2016
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.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 effects of stenosis and ischemia are listed in the xience prime everolimus eluting coronary stent systems instructions for use are known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects 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 other xience prime stent referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2013, the patient was hospitalized with ischemia.A coronary stenting procedure was performed on (b)(6) 2013, with implantation of a 3.0 x 33 mm xience prime stent and a 3.5 x 28 mm xience prime stent in the left anterior descending artery.On (b)(6) 2016, the patient experienced a serious episode of ischemia and in-stent restenosis was noted within the xience stents.Additionally, a new area of stenosis was noted in the circumflex artery.On (b)(6) 2016, angioplasty was performed, using a drug coated balloon, to treat the restenosis of the xience prime stents.Intervention was performed, treating the circumflex artery, with implantation of an unspecified drug eluting stent.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: 7034556
• Report Number: 2024168-2017-08997
• Device Sequence Number: 19251613
• Product Code: NIQ
• UDI-Device Identifier: 08717648177187
• UDI-Public: 08717648177187
• 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): 11/15/2017

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 Catalogue Number: 1011733-33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/15/2017
• 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: STENT: 3.5X28MM XIENCE PRIME
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 63