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

Catalog Number	1125300-23
Health Effect - Clinical Codes	Angina (1710); Perforation (2001)
Date of Event	03/22/2018
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.The reported patient effects of angina and perforation are listed in the instructions for use xience alpine everolimus eluting coronary stent systems as 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional 2.8 x 16mm rx graftmaster device is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a non-tortuous, non-calcified left anterior descending (lad) coronary artery.A 3.0 x 23mm xience alpine stent was deployed at 12 atmospheres.Post-stent implantation, a perforation of the lad was noted.Two rx graftmasters (2.8 x 16mm and 2.8 x 19mm) were used to treat the lesion.The 2.8 x 16mm rx graftmaster was attempted to seal the perforation, but was too small.Then a 2.8 x 19mm rx graftmaster was additionally used to successfully seal the perforation.The patient experienced some chest pain after the two rx grafmasters were implanted.An echocardiogram was performed and it was noted that there was a small pericardial effusion around the xience alpine and 2.8 x 16mm graftmaster, however, the area where the 2.8 x 19mm graftmaster was placed was fully sealed.The small pericardial effusion was not treated.Patient recovered fine.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 7400287
• Report Number: 2024168-2018-02504
• Device Sequence Number: 61795
• Product Code: NIQ
• UDI-Device Identifier: 08717648199363
• UDI-Public: 08717648199363
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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: 01/31/2021
• Device Catalogue Number: 1125300-23
• Device Lot Number: 8012041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/05/2018
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 58