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

Catalog Number	1235350-23
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226)
Date of Event	12/22/2016
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.Concomitant medical devices: dilatation catheter: 3.5 x 15, 3.75 x 15 and 4.0 x 15 mm nc trek.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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 perforation and cardiac tamponade, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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 design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous and moderately calcified proximal left anterior descending artery.The patient presented with a tachycardia induced cardiomyopathy and the left ventricular (lv) function was 20.Pre-dilatation was performed with a 3.25 x 15 mm nc trek and a 3.5 x 15 nc trek balloon catheters to 16 atmospheres.A 3.5 x 23 mm absorb gt1 scaffold was implanted at 12 atmospheres (atms) for 20 seconds.Optical coherence tomography was performed and the scaffold was fully apposed to the vessel wall.Post-dilatation was performed with a 3.5 x 15 mm nc trek to 20 atms, a 3.75 x 15 mm nc trek to 24 atms and then a 4.0 x 12 mm nc trek at 20 atms when a perforation occurred.The perforation was treated with a 3.75 x 15 mm unspecified balloon catheter at 9 atms for 4 1/2 minutes.The blood flow was still slow, so a 3.5 x 28 mm xience alpine was implanted in the ostial lesion of the lad and was post-dilated with a 3.75 x 20 mm nc trek balloon catheter to 15 atmospheres and the distal flow increased.A pericardiocentesis was performed due to the perforation.A balloon pump was put in the patient due to the low lv function.The patient was admitted to the intensive care unit.There was a 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: 6244393
• Report Number: 2024168-2017-00356
• Device Sequence Number: 1477907
• Product Code: PNY
• UDI-Device Identifier: 08717648213137
• UDI-Public: (01)08717648213137(17)170808(10)6080961
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/11/2017

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: 08/08/2017
• Device Catalogue Number: 1235350-23
• Device Lot Number: 6080961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/11/2017
• 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: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 132