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

Catalog Number	1076300-15
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system was advanced resistance was met with the mildly tortuous and heavily calcified anatomy resulting in the reported failure to advance and the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and heavily calcified lesion in the mid left anterior descending artery (lad).Following pre-dilatation with a couple of balloon catheters, a 3.0x15mm xience prox stent delivery system (sds) was advanced in the lad; however, the sds failed to cross due to the anatomy.The stent became stuck in a curve of the lad and the stent could not be moved.It was assumed that there was a high grade of stenosis so the stent was deployed with a good result.Additional pre-dilatation was performed and a non-abbott stent was implanted.There was residual stenosis in the non-abbott stent; therefore, another stent was placed in between.The procedure was successfully completed with post-dilatation and the patient outcome was good.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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: 6804839
• Report Number: 2024168-2017-06798
• Device Sequence Number: 16180613
• Product Code: NIQ
• UDI-Device Identifier: 08717648199189
• UDI-Public: 08717648199189
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1076300-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1