MAUDE Adverse Event Report: AV-TEMECULA-CT MULTI-LINK RX VISION CORONARY STENT SYSTEM

Catalog Number	1007848-18
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Additionally, the reported treatment appears to be related to the operational context of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, there is no indication of a product quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The graftmaster device referenced is being filed under a separate manufacturer report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in a severely tortuous and calcified lesion located in the posterior descending artery.After deployment of the 3.0 x 18 mm rx vision stent a perforation was observed.A 2.8 x 19 mm graftmaster stent delivery system was advanced for treatment; however, would not cross.A balloon was advanced and inflated successfully sealing the perforation.No additional information was provided.

• Brand Name: MULTI-LINK RX VISION CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6490118
• Report Number: 2024168-2017-03122
• Device Sequence Number: 747046
• Product Code: MAF
• UDI-Device Identifier: 08717648050633
• UDI-Public: (01)08717648050633(17)190331(10)6040441
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: 03/31/2019
• Device Catalogue Number: 1007848-18
• Device Lot Number: 6040441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2017
• Initial Report FDA Received Date: 04/13/2017
• 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: Required Intervention
• Patient Age: 88 YR
• Patient Weight: 62