MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235350-18
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effects of perforation, as listed in the absorb gt1 instructions for use, is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a lesion with no tortuosity and no calcification in the mid right coronary artery (rca).The 3.5 x 18 mm absorb gt1 was deployed at the target lesion successfully with good results.Post dilatation was performed using a 4.0 x 12 mm nc trek to 18 atmospheres; however, a perforation occurred.A 4.0 x 16 mm graftmaster was used to successfully seal the perforation.The patient outcome was good.There was no adverse patient sequela.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6176080
• Report Number: 2024168-2016-08888
• Device Sequence Number: 11011271
• Product Code: PNY
• UDI-Device Identifier: 08717648213120
• UDI-Public: (01)08717648213120
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: 1235350-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 12/15/2016
• 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: DILATATION CATHETER: 4.0 X 12 MM NC TREK
• Outcome Attributed to Adverse Event: Required Intervention